OpenLegislation

The Human Medicines Regulations 2012

S.I. 2012/1916 · Made 19 July 2012 · Extends to United Kingdom

Not fully up to date. 9 changes made by later legislation have not yet been written into this text, which is revised to 31 March 2026.

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ProvisionChangeMade by
reg. 4AinsertedThe Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 art. 5
reg. 220AinsertedThe Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 art. 7(3)
reg. 8(1)words insertedThe Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 art. 12(2)
reg. 167(2)(b)words insertedThe Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 art. 12(6)
reg. 222A(4)words insertedThe Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 art. 12(11)
reg. 274(2)(a)words insertedThe Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 art. 12(15)
reg. 346(2)(c)(xxviiieza)insertedThe Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 art. 12(16)(a)
Sch. 25 para. 6Awords insertedThe Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 art. 12(17)
Sch. 26 para. 10Awords insertedThe Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 art. 12(18)

Medicines

Made 19th July 2012

Laid before Parliament 24th July 2012

Coming into force 14th August 2012

The Secretary of State and the Minister for Health, Social Services and Public Safety make the following Regulations. They do so in exercise of the powers conferred by section 2(2) and (5) of the European Communities Act 1972M1, having been designated for the purposes of section 2(2) of that Act in relation to medicinal productsM2 and to measures in the veterinary and phytosanitary fields for the protection of public healthM3. They do so in exercise also of the powers conferred by sections 87(1), 88(1) and (2), 91(2), and 129(1), (2) and (5) of the Medicines Act 1968M4, having consulted such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations in accordance with section 129(6) of that Act.C1

Annotations to the whole text

Marginal citations

M1

1972 c.68. Section 2(2) was amended by section 27(1)(a) of the Legislative Reform Act 2006 (2006 c,51) and section 3(3) of and Part 1 of the Schedule to the European Union (Amendment) Act 2008 (2008 c.7). Section 2(5) was amended by section 41(1) of and Part 1 of Schedule 6 to the Northern Ireland Constitution Act 1973 (1973 c.36).

M2

S.I. 1972/1811.

M3

S.I. 1999/2027.

M4

1968 c.67.

Modifications

C1

Instrument modified (10.5.2013) by The National Health Service (Pharmaceutical Services) (Wales) Regulations 2013 (S.I. 2013/898), reg. 2(5)

Contents

  1. Part 1: General
  2. 1Citation and commencement
  3. 2Medicinal products
  4. 2ADefinition of advanced therapy medicinal product etc.
  5. 3Scope of these Regulations: special provisions
  6. 3APreparation and assembly of medicinal products used for vaccination against an infectious disease or in the reformulation of such products
  7. 4Special provisions for pharmacies etc
  8. 5Classification of medicinal products
  9. 6The licensing authority and the Ministers
  10. 7Advertisements relating to medicinal products
  11. 8General interpretation
  12. Part 2: Administration
  13. 9Commission on Human Medicines
  14. 10Functions of the Commission
  15. 11British Pharmacopoeia Commission
  16. 12Reporting to Ministers
  17. 13Co-option of additional members of advisory bodies
  18. 14Appointment of expert advisory groups
  19. 15Delegation of functions to expert advisory groups
  20. 16Further provision about advisory bodies and expert advisory groups etc
  21. Part 3: Manufacture and distribution of medicinal products and active substances
  22. Chapter 1: Interpretation
  23. A17Interpretation
  24. Chapter 1A: Good manufacturing practice and good distribution practice
  25. B17Regulations on good manufacturing practice
  26. C17Guidelines on good manufacturing practice and good distribution practice
  27. Chapter 2: Manufacturing and wholesale dealing
  28. Grant etc of licences
  29. 17Manufacturing of medicinal products
  30. 17AManufacturing of MM medicinal products
  31. 17BManufacturing of POC medicinal products
  32. 18Wholesale dealing in medicinal products
  33. 18AApproved country for import
  34. 19Exemptions from requirement for wholesale dealer's licence
  35. 20Mixing of medicines
  36. 21Application for manufacturer's or wholesale dealer's licence
  37. 22Factors relevant to determination of application for manufacturer's or wholesale dealer's licence
  38. 23Grant or refusal of licence
  39. 24Standard provisions of licences
  40. 25Duration of licence
  41. 26General power to suspend, revoke or vary licences
  42. 27Procedure where licensing authority proposes to suspend, revoke or vary licence
  43. 27AEffect of suspension or variation relating to modular unit or POC site
  44. 28Suspension of licence in cases of urgency
  45. 29Variation of licence on the application of the holder
  46. 29AVariation of MM master file
  47. 29BVariation of POC master file
  48. 30Provision of information
  49. Miscellaneous and offences
  50. 31Certification of manufacturer's licence
  51. 32Sale and supply of starting materials Repealed
  52. 33Offence concerning data for advanced therapy medicinal products
  53. 34Offences: breach of regulations and false information and defence concerning starting materials
  54. 35Penalties
  55. Conditions for holding a manufacturer's licence
  56. 36Conditions for manufacturer's licence
  57. 37Manufacturing and assembly
  58. 37AManufacturing and assembly of MM medicinal products: additional requirements
  59. 37BManufacturing and assembly of POC medicinal products: additional requirements
  60. 38Imports from states other than EEA States / countries other than approved countries for import
  61. 39Further requirements for manufacturer's licence
  62. 40Obligation to provide information relating to control methods
  63. 41Requirements as to qualified persons
  64. Conditions for holding a wholesale dealer's licence
  65. 42Conditions for wholesale dealer's licence
  66. 43Obligations of licence holder
  67. 43ZAObligations of licence holder in Great Britain supplying listed NIMAR products to Northern Ireland
  68. 43ARequirement for wholesale dealers to decommission the unique identifier Repealed
  69. 44Requirement for wholesale dealers to deal only with specified persons
  70. 45Requirement as to responsible persons
  71. 45AARequirement as to responsible persons where licence holder imports from an approved country for import
  72. 45ABRegister for responsible persons (import)
  73. Chapter 3: Brokering
  74. 45ABrokering in medicinal products
  75. 45BApplication for brokering registration
  76. 45CProcedure for determining an application for broker’s registration
  77. 45DGrant or refusal of broker’s registration
  78. 45ECriteria of broker’s registration
  79. 45FProvision of information
  80. 45GPower to suspend or vary a broker’s registration or remove a broker from the register
  81. 45HProcedure where licensing authority proposes to suspend or vary a broker’s registration or remove a broker from the register
  82. 45ISuspension of a broker registration in cases of urgency
  83. 45JVariation of a broker’s registration on the application of the broker
  84. 45KOffences: breach of regulations and false information
  85. 45LPenalties
  86. Chapter 4: Importation, manufacture and distribution of active substances
  87. 45MCriteria for importation, manufacture or distribution of active substances
  88. 45NRegistration in relation to active substances
  89. 45ORequirements for registration as an importer, manufacturer or distributor of an active substance
  90. 45PProvision of information
  91. 45QPower to suspend or vary or remove an active substance registration
  92. 45RProcedure where licensing authority proposes to suspend or vary an active substance registration or remove a person from the active substance register
  93. 45SSuspension of an active substance registration in cases of urgency
  94. 45TVariation of an active substance registration on an application from the registered person
  95. 45UOffences: breach of regulations and false information
  96. 45VPenalties
  97. Part 4: Requirement for authorisation
  98. 46Requirement for authorisation
  99. 47Breach of requirement
  100. Part 5: Marketing authorisations
  101. 48Application of this Part
  102. Application for UK marketing authorisation
  103. 49Application for grant of UK marketing authorisation or parallel import licence
  104. 50Accompanying material
  105. 50ARequirement for certain applications to include results of paediatric investigation plan
  106. 50BAgreement and modification of paediatric investigation plan
  107. 50CDeferral of initiation or completion of measures in paediatric investigation plan
  108. 50DWaiver of production of information in a paediatric investigation plan
  109. 50EApplication for paediatric use marketing authorisation
  110. 50FOther applications including paediatric indications
  111. 50GApplications relating to orphan medicinal products
  112. 50HApplications relating to advanced therapy medicinal products
  113. 50IApplications relating to conditional marketing authorisations ...
  114. 50JApplications in relation to medicinal products containing or consisting of genetically modified organisms
  115. 50KApplications relating to POC medicinal products
  116. 51Application for UKMA(NI) relating to generic medicinal products
  117. 51AApplication for UKMA(GB) relating to generic medicinal products Repealed
  118. 51BApplication for UKMA(UK) relating to generic medicinal products
  119. 52Application for UKMA(NI) relating to certain medicinal products that do not qualify as generic etc
  120. 52AApplication for UKMA(GB) relating to certain medicinal products that do not qualify as generic etc Repealed
  121. 52BApplication for UKMA(UK) relating to certain medicinal products that do not qualify as generic etc.
  122. 53Application for UKMA(NI) relating to similar biological medicinal products
  123. 53AApplication for UKMA(GB) relating to similar biological medicinal products Repealed
  124. 53BApplication for UKMA(UK) relating to similar biological medicinal products
  125. 54Applications relating to products in well-established medicinal use
  126. 55Applications relating to new combinations of active substances
  127. 56Applications containing information supplied in relation to another product with consent
  128. 57Obligation to update information supplied in connection with application
  129. 57AObligation to update information supplied in connection with parallel import licence application
  130. Consideration of application
  131. 58Consideration of application
  132. 58APaediatric rewards
  133. 58BPublication of information relating to paediatric marketing authorisations
  134. 58CConsideration of applications relating to orphan medicinal products
  135. 58DOrphan rewards
  136. 58EConsideration of applications relating to combined advanced therapy medicinal products
  137. 58FConsideration of applications relating to conditional marketing authorisations
  138. 58GConsideration of applications in relation to medicinal products containing or consisting of genetically modified organisms
  139. 59Conditions of UK marketing authorisation or parallel import licence: general
  140. 60Conditions of UK marketing authorisation or parallel import licence: exceptional circumstances
  141. 60ACondition as to the submitting of samples and other information to the appropriate authority
  142. 60BSubmitting of samples and other information: EU marketing authorisations Repealed
  143. 61Conditions of UK marketing authorisation: new obligations post-authorisation
  144. 62Classification of UK marketing authorisation or parallel import licence
  145. 63Frequency of periodic safety update reports
  146. 64Duties of licensing authority in connection with determination
  147. 64AObligation of licensing authority in case of change of classification
  148. Validity of UK marketing authorisation
  149. 65Validity of UK marketing authorisation
  150. 65AValidity of parallel import licence
  151. 65BValidity of conditional marketing authorisation
  152. 65CVariation of a UKMA(GB) or a UKMA(UK)(Category 1)
  153. 66Application for renewal of authorisation
  154. 66AApplication for renewal of a parallel import licence
  155. 66BRenewal of conditional marketing authorisation
  156. 67Failure to place on the market etc
  157. Revocation, variation and suspension of marketing authorisation
  158. 68Revocation, variation and suspension of UK marketing authorisation or parallel import licence
  159. 69Suspension of use etc of relevant medicinal product
  160. 70Authorisations granted under Chapter 4 of Title III of the 2001 Directive Repealed
  161. 71Withdrawal of medicinal product from the market
  162. 72Sale etc of suspended medicinal product
  163. Obligations of holder of marketing authorisation
  164. 73Obligation to notify placing on the market etc
  165. 74Obligation to take account of scientific and technical progress
  166. 74AObligation to provide information relating to methods of manufacture and control: MM medicinal products
  167. 74BObligation to provide information relating to methods of manufacture and control: POC medicinal products
  168. 75Obligation to provide information relating to safety etc
  169. 76Obligation in relation to product information
  170. 77Record-keeping obligations
  171. 78Obligation to ensure appropriate and continued supplies
  172. 78APost authorisation requirements in relation to UK marketing authorisations to which paediatric specific provisions apply
  173. 78BPost authorisation requirements in relation to UKMA(UK)(Category 1) for advanced therapy medicinal products
  174. Offences relating to specific requirements
  175. 79Failure to provide information on marketing authorisations to EMA
  176. 80Urgent safety restrictions
  177. 80AUrgent safety restrictions: parallel import licences
  178. Offences relating to EU marketing authorisations
  179. A81Application of regulations 89 to 94
  180. 81Obligation to update information supplied in connection with EU application Repealed
  181. 82EU marketing authorisations: failure to notify placing on market etc Repealed
  182. 83EU marketing authorisations: failure to take account of technical and scientific progress Repealed
  183. 84EU marketing authorisations: failure to provide information as to safety etc Repealed
  184. 85EU marketing authorisations: failure to update product information Repealed
  185. 86EU marketing authorisations: breach of pharmacovigilance condition etc Repealed
  186. Offences relating to advanced therapy medicinal products
  187. 87Offences in connection with risk management systems and traceability systems Repealed
  188. 88Offence concerning data for advanced therapy medicinal products Repealed
  189. Offences relating to the Paediatric Regulation
  190. 89Offences in connection with withdrawal of product from the market
  191. 90Failure to place on the market taking account of paediatric indication
  192. 91Failure to notify results of third country clinical trials Repealed
  193. 92Failure of sponsor of UK paediatric clinical trial to notify results of trial
  194. 93Failure to notify results of paediatric study
  195. 94Failure to submit report to EMA
  196. Offences relating to the safety features appearing on the packaging of medicinal products
  197. 94AOffences relating to Commission Regulation 2016/161 Repealed
  198. General provisions relating to offences
  199. 95Offences in connection with application
  200. 95AOffences in connection with parallel import licence application
  201. 96Provision of false or misleading information
  202. 97Breach of pharmacovigilance condition
  203. 98General offence of breach of provision of this Part
  204. 99Penalties
  205. 100Persons liable
  206. 101Defences
  207. Part 6: Certification of homoeopathic medicinal products
  208. Application of Part
  209. 102Application of Part
  210. Application for certificate of registration and consideration of application
  211. 103Application for certificate of registration
  212. 104Consideration of application
  213. 105Conditions of certificate of registration
  214. 106Classification of certificate of registration
  215. 107Validity of certificate of registration
  216. 108Application for renewal of certificate
  217. 109Failure to place on the market etc
  218. Revocation, variation and suspension of certificate of registration
  219. 110Revocation, variation and suspension of certificate of registration
  220. 111Certificates granted under Chapter 4 of Title III of the 2001 Directive Repealed
  221. 112Withdrawal of homoeopathic medicinal product from the market
  222. Obligations of holder of certificate of registration
  223. 113Obligation to notify placing on the market etc
  224. 114Obligation to take account of scientific and technical progress
  225. 115Obligation to provide information relating to safety etc
  226. 116Obligation in relation to product information
  227. 117Record-keeping obligation
  228. 118Obligation to ensure appropriate and continued supplies
  229. Provisions relating to offences
  230. 119Offences in connection with applications
  231. 120Provision of false or misleading information
  232. 121General offence of breach of provision of this Part
  233. 122Penalties
  234. 123Persons liable
  235. 124Defences
  236. Part 7: Traditional herbal registrations
  237. Interpretation and application of Part
  238. 124AInterpretation of this Part
  239. 125Traditional herbal medicinal products
  240. 125AList of approved countries for traditional use of a herbal medicinal product
  241. 126Addition of vitamins or minerals
  242. List of herbal substances, preparations and combinations for use in traditional herbal medicinal products
  243. 126ALicensing authority list as to herbal substances, preparations and combinations for use in traditional herbal medicinal products
  244. Application for traditional herbal registration
  245. 127Application for grant of traditional herbal registration
  246. 128Accompanying material
  247. 129Obligation to update information supplied in connection with application
  248. Consideration of application
  249. 130Consideration of application
  250. 130AProcedure where less than 15 years use of traditional herbal medicinal product
  251. 131Classification of traditional herbal registration
  252. Validity of traditional herbal registration
  253. 132Validity of traditional herbal registration
  254. 133Application for renewal of registration
  255. 134Failure to place on the market etc
  256. Revocation, variation and suspension of traditional herbal registration
  257. 135Revocation, variation and suspension of traditional herbal registration
  258. 136Revocation by licensing authority: further provisions
  259. 137Procedures for revocation, variation or suspension
  260. 138Suspension of use etc of traditional herbal medicinal product
  261. 139Registrations granted under Chapter 4 of Title III of the 2001 Directive Repealed
  262. 140Withdrawal of traditional herbal medicinal product from the market
  263. 141Sale etc of suspended traditional herbal medicinal product
  264. Obligations of holder of traditional herbal registration
  265. 142Obligation to notify placing on the market etc
  266. 143Obligation to take account of scientific and technical progress
  267. 143AEstablishment of herbal monographs
  268. 144Obligation following new herbal monograph
  269. 145Obligation to provide information relating to safety etc
  270. 146Obligation in relation to product information
  271. 147Record-keeping obligations
  272. 148Obligation to ensure appropriate and continued supplies
  273. 148AUrgent safety restrictions
  274. Offences relating to traditional herbal registrations
  275. 149Urgent safety restrictions
  276. 150Offences in connection with applications
  277. 151Provision of false or misleading information
  278. 152General offence of breach of provision of this Part
  279. 153Penalties
  280. 154Persons liable
  281. 155Defences
  282. Part 8: Article 126a authorisations
  283. 156Article 126a authorisations
  284. 157Requests from EU member States
  285. 158Application of these Regulations
  286. Part 9: Borderline products
  287. 159Provisional determination
  288. 160Challenge to provisional determination
  289. 161Written representations procedure
  290. 162Oral representations procedure
  291. 163Final determination without representations
  292. 164Effect of final determination
  293. 165Determination in other cases
  294. 166Offences relating to borderline products
  295. Part 10: Exceptions to requirement for marketing authorisation etc
  296. Exceptions
  297. 167Supply to fulfil special patient needs
  298. 167ANIMAR supply to Northern Ireland
  299. 167BList of NIMAR products
  300. 167CEarly Access to Medicines Scheme: establishment and licensing authority functions
  301. 167DEAMS scientific opinions ceasing to have effect
  302. 167EEAMS medicinal products: manufacture, assembly, importation, distribution and supply
  303. 167FAdvertising of EAMS medicinal products
  304. 167GEAMS medicinal products: pharmacovigilance
  305. 167HEarly Access to Medicines Scheme: data collection
  306. 168Use of non-prescription medicines in the course of a business
  307. 169Mixing of general sale medicinal products
  308. 170Record-keeping requirements
  309. 170AMM medicinal products: pharmacovigilance requirements
  310. 170BPOC medicinal products: pharmacovigilance requirements
  311. 171Exempt advanced therapy medicinal products
  312. 172Parallel import licences
  313. 173Exemption for certain radiopharmaceuticals
  314. 174Supply in response to spread of pathogenic agents etc
  315. 174AConditions of temporary authorisations under regulation 174
  316. Offences
  317. 175Offences relating to exceptions
  318. 176Penalties and supplementary provision about offences
  319. Part 11: Pharmacovigilance
  320. 177Application of this Part and interpretation
  321. Obligations on licensing authority in relation to pharmacovigilance
  322. 178General obligations of the licensing authority
  323. 179Obligation on licensing authority to operate pharmacovigilance system
  324. 180Obligation on licensing authority to audit pharmacovigilance system
  325. 181Delegation of obligations under this Part
  326. Obligations on holders in relation to pharmacovigilance system
  327. 182Obligation on holder to operate pharmacovigilance system
  328. 183Exception to obligation to operate risk management system
  329. 184Obligation on holder to audit pharmacovigilance system
  330. Recording, reporting and assessment of pharmacovigilance data
  331. 185Recording obligations on the licensing authority
  332. 186Reporting obligations on the licensing authority
  333. 186ARegulation 186A
  334. 187Recording obligations on holders
  335. 188Reporting obligations on holders
  336. Signal detection
  337. 189Signal detection: licensing authority obligations
  338. 190Signal detection: holder obligation
  339. Periodic Safety Update Reports
  340. 191Obligation on holder to submit periodic safety update reports: general requirements
  341. 191AObligation on holder of a parallel import licence to submit periodic safety update reports
  342. 192Obligation on holder to submit periodic safety update reports: derogation from general requirements
  343. 193Harmonisation of PSUR frequency or date of submission
  344. 194Responding to a single assessment of PSUR under Article 107e of the 2001 Directive
  345. 195Obligation on licensing authority to assess PSURs ...
  346. Urgent action and major safety review
  347. 196Urgent action
  348. 196AMajor safety review by the licensing authority
  349. 197EU urgent action procedure
  350. Post-authorisation safety studies
  351. 198Post-authorisation safety studies: general provisions
  352. 199Submission of draft study protocols for required studies
  353. 200Amendment to study protocols for required studies
  354. 201Submission and evaluation of final study reports for required studies
  355. 202Follow-up of final study reports
  356. Medicinal products subject to additional monitoring
  357. 202ALicensing authority power in relation to medicinal products subject to additional monitoring
  358. Transparency and communications
  359. 203Obligations on licensing authority in relation to national medicines web-portal
  360. 204Obligation on licensing authority in relation to public announcements
  361. 205Obligations on holders in relation to public announcements
  362. Further obligations in respect of pharmacovigilance activities
  363. 205AFurther obligations in respect of pharmacovigilance activities
  364. Guidance in respect of pharmacovigilance
  365. 205BGuidance in respect of good pharmacovigilance practice and post authorisation efficacy studies
  366. Enforcement
  367. 206Infringement notices
  368. 207Offences
  369. 208False and misleading information
  370. 209Penalties
  371. 210Offences relating to pharmacovigilance obligations under Regulation (EC) No 726/2004 Repealed
  372. 210AOffences in relation to pharmacovigilance obligations under the Implementing Regulation and Schedule 12A
  373. 211Persons liable
  374. Transitional arrangements
  375. 212Transitional arrangements
  376. Part 12: Dealings with medicinal products
  377. Chapter 1: Interpretation
  378. 213Interpretation
  379. Chapter 2: Sale and supply of medicines
  380. Prescription only medicines
  381. 214Sale or supply of prescription only medicines
  382. 215Prescribing and administration by supplementary prescribers
  383. 216Exceptions to regulation 215
  384. 217Requirements for prescriptions: general
  385. 217ARequirements for prescriptions to be dispensed in an EEA state ...
  386. 217BOriginal pack dispensing
  387. 217BAOriginal pack dispensing: Northern Ireland
  388. 217COriginal pack dispensing: medicinal products containing a relevant substance
  389. 217CAOriginal pack dispensing: medicinal products containing a relevant substance: Northern Ireland
  390. 218Requirements for prescriptions: approved country health professional
  391. 219Electronic prescriptions
  392. 219AElectronic Prescriptions: approved country health professionals
  393. Medicines not subject to general sale
  394. 220Sale or supply of medicinal products not subject to general sale
  395. General sale medicines
  396. 220BSale or supply of items dispensed by a pharmacist who is absent or treated as absent
  397. 221Sale or supply of medicinal products subject to general sale
  398. 222Sale of medicinal products from automatic machines
  399. 222AAssembly or part-assembly as part of “hub and spoke” dispensing arrangements between different businesses
  400. 222BHub and spoke arrangements: sharing of data between different businesses
  401. Chapter 3: Exemptions
  402. Exemptions relating to supply in specific circumstances
  403. 223Exemptions for doctors and dentists etc
  404. 224Emergency sale etc by pharmacist: prescriber unable to provide prescription
  405. 225Emergency sale etc by pharmacist: at patient's request
  406. 226Emergency sale etc by pharmacist: pandemic diseases
  407. 226ASale etc by a pharmacist in accordance with a serious shortage protocol
  408. 227Exemption for sale or supply in hospitals
  409. 228Exemptions relating to prescriptions given by certain health professionals
  410. 229Exemption for supply by national health service bodies and local authorities
  411. 230Exemption for supply etc under a PGD to assist doctors or dentists
  412. 231Exemption for supply etc under a PGD by independent hospitals etc
  413. 232Exemption for supply etc under a PGD by dental practices and clinics: England and Wales
  414. 233Exemption for supply etc under a PGD by person conducting a retail pharmacy business
  415. 234Exemption for supply etc of products under a PGD to assist the police etc
  416. 235Exemption for sale, supply or administration by certain persons
  417. 235AExemption for supply or administration of certain medicines used for vaccination
  418. Exemptions in relation to specific kinds of product
  419. 236Products consisting of or containing aloxiprin, aspirin or paracetamol
  420. 237Products consisting of or containing pseudoephedrine salts or ephedrine base or salts
  421. 237AAppropriate suppliers of naloxone products
  422. 238Administration of certain medicines in an emergency
  423. 239Administration of smallpox vaccine
  424. 240Radioactive medicinal products
  425. 241Exemptions in respect of certain herbal remedies
  426. 242Exemption for medicinal products at high dilution
  427. 243Exemption for certain homoeopathic medicinal products
  428. Other exemptions
  429. 244Exemption in cases involving another's default
  430. 245Exemption in case of forged prescription
  431. 246Exemption where requirements for prescriptions not met
  432. 247Exemption for supply in the event or anticipation of pandemic disease
  433. 247AProtocols relating to coronavirus and influenza vaccinations and immunisations Repealed
  434. 248Exemption for certain collection and delivery arrangements
  435. Chapter 4: Miscellaneous provisions, offences and disqualification
  436. Miscellaneous provisions
  437. 249Restrictions on persons to be supplied with medicinal products
  438. 250Exceptions to regulation 249
  439. 251Compliance with standards specified in certain publications
  440. 252Compliance with standards specified in certain publications: supplementary
  441. 253Pharmacy records
  442. 254Prohibitions concerning traceability of treatment with advanced therapy medicinal products
  443. 255Offences relating to dealings with medicinal products
  444. 255AEnforcement notices relating to Commission Regulation 2016/161: persons authorised to supply medicinal products to the public Repealed
  445. 255BException to Article 25 of Commission Regulation 2016/161: health care institutions Repealed
  446. 255COffences relating to Commission Regulation 2016/161: management of the repository system Repealed
  447. Disqualification
  448. 256Disqualification on conviction
  449. Part 12A: Sale of medicines to the public at a distance
  450. 256ZAApplication of Part
  451. 256AInterpretation
  452. 256BPerson who may sell medicinal products by information society services
  453. 256CNotification requirements for sellers of medicinal products at a distance
  454. 256DProcedure for listing persons who may supply medicinal products at a distance
  455. 256ERemoval of a person’s entry from the list
  456. 256FProvision of information to the licensing authority
  457. 256GGrant or refusal to list a person
  458. 256HConditions to be met by a person entered on the list
  459. 256IPower to suspend, vary or remove a person’s entry on the list
  460. 256JProcedure where the licensing authority proposes to suspend, vary or remove a person’s entry on the list
  461. 256KSuspension of a person’s entry on the list in cases of urgency
  462. 256LVariation of a person’s entry on the list on the application of that person
  463. 256MOffences: breach of regulations and false information
  464. 256NPenalties
  465. Part 13: Packaging and leaflets
  466. Chapter 1
  467. Requirements for packaging and package leaflets relating to medicinal products
  468. 257Packaging requirements: general
  469. 257AAPackaging requirements: variation in accordance with regulation 68(11I)
  470. 257ABTransitional arrangements
  471. 257APackaging Requirements: medicinal products required to bear safety features Repealed
  472. 257BTransitional Arrangements Repealed
  473. 257CPackaging requirements: advanced therapy medicinal products
  474. 257CAPackaging requirements: POC medicinal products
  475. 257DGuidance as to packaging and package leaflets
  476. 257ERegulation-making power as to certain forms of labelling
  477. 258Packaging requirements: specific provisions
  478. 259Packaging requirements: information for blind and partially sighted patients
  479. 260Package leaflets
  480. 261Use of pictures and symbols etc
  481. 262Labelling requirements for radionuclides
  482. 263Leaflets relating to radionuclides
  483. 264Homoeopathic medicines
  484. 265Additional requirements for traditional herbal medicinal products
  485. 266Language requirements etc
  486. 267Submission of mock-ups of packaging and leaflets to licensing authority
  487. Enforcement and offences
  488. 268Offence relating to packaging and package leaflets in Great Britain: holder of authorisation etc
  489. 268AOffence relating to packaging and package leaflets in Northern Ireland: holder of authorisation etc
  490. 269Offences relating to packaging and package leaflets in Great Britain: other persons
  491. 269AOffences relating to packaging and package leaflets in Northern Ireland: other persons
  492. 270Non-compliance with requirements of this Part
  493. 271Offences: penalties
  494. Chapter 2
  495. Requirements relating to child safety
  496. 272Interpretation
  497. 273Child resistant containers for regulated medicinal products
  498. 274Exemptions from regulation 273
  499. 275Colouring of aspirin and paracetamol products for children
  500. 276Offences
  501. Part 14: Advertising
  502. Chapter 1: General
  503. 277Interpretation
  504. 278Functions of the Ministers
  505. Chapter 2: Requirements relating to advertising
  506. General
  507. 279Products without a marketing authorisation etc
  508. 280General principles
  509. 281Duties of authorisation holders and registration holders
  510. Advertising to the public
  511. 282Application of regulations 283 to 292
  512. 283Products for the purpose of inducing abortions
  513. 284Prescription only medicines
  514. 284AMedicines with differing classification status in Great Britain and Northern Ireland
  515. 285Narcotic and psychotropic substances
  516. 286Material relating to diagnosis
  517. 287Material about effects of medicinal product
  518. 288Material about status of medicinal product
  519. 289Recommendations by scientists etc
  520. 290Advertisements directed at children
  521. 291Form and content of advertisement
  522. 291ACampaigns relating to the suspected or confirmed spread of pathogenic agents etc.
  523. 292Exception for approved vaccination campaigns
  524. Prohibition of supply to the public for promotional purposes
  525. 293Prohibition of supply to the public for promotional purposes
  526. Advertising to persons qualified to prescribe or supply etc
  527. 294General requirements
  528. 295Abbreviated advertisements
  529. 296Exception for advertisements intended as a reminder
  530. 297Written material accompanying promotions
  531. 298Free samples for persons qualified to prescribe or supply medicinal products
  532. 299Medical sales representatives
  533. 300Inducements and hospitality
  534. Homoeopathic medicinal products
  535. 301Advertisements for registered homoeopathic medicinal products
  536. Traditional herbal medicinal products
  537. 302Advertisements for traditional herbal medicinal products
  538. Offences
  539. 303Offences
  540. Chapter 3: Monitoring of Advertising
  541. Scrutiny by Ministers
  542. 304Requirement to provide copy advertisement
  543. 305Invitation to make representations about compatibility
  544. 306Decision about compatibility
  545. 307Corrective statement
  546. 308Offences
  547. Complaints to Ministers
  548. 309Complaints to Ministers: duty to consider
  549. 310Complaints to Ministers: power to refer
  550. Injunctions
  551. 311Application for injunction
  552. 312Application for injunction: accuracy of factual claim
  553. 313Grant of injunction: publication of decision and corrective statement
  554. Complaints to OFCOM
  555. 314Complaints to OFCOM
  556. General
  557. 315Public interest etc
  558. 316Civil proceedings
  559. Part 15: British Pharmacopoeia
  560. 317British Pharmacopoeia and compendia
  561. 318Lists of names
  562. 319Other documents
  563. 320Supplementary provisions
  564. 321Specified publications
  565. Part 16: Enforcement
  566. 322Validity of decisions and proceedings
  567. 323Enforcement in England, Wales and Scotland
  568. 324Enforcement in Northern Ireland
  569. 325Rights of entry
  570. 326Application for warrant
  571. 327Powers of inspection, sampling and seizure
  572. 328Regulation 327: supplementary
  573. 329Application of sampling procedure to substance or article seized under this Part
  574. 330Analysis of samples: other cases
  575. 331Findings and reports of inspections
  576. 331AGuidelines on inspections
  577. 332Restrictions on disclosure of information
  578. 333Protection for inspectors
  579. 334Supplementary provisions and offences
  580. Part 17: Miscellaneous and general
  581. Provisions relating to offences
  582. 335Contravention due to fault of another person
  583. 336Warranty as defence
  584. 337Offences in relation to warranties and certificates
  585. 338Offences by bodies corporate and partnerships
  586. Prosecutions
  587. 339Prosecutions
  588. General
  589. 340Presumptions
  590. 341Decisions under these Regulations
  591. 342Time limits for provision of information etc
  592. 343Service of documents
  593. 344Payment of expenses by Ministers
  594. 344AModifications to deal with serious shortages
  595. 344BRegulation making powers
  596. Immunity from civil liability
  597. 345Immunity from civil liability
  598. 345AObligation on licensing authority to maintain list of medicinal products to which derogations have applied
  599. Review
  600. 346Review
  601. Transitional provisions, savings, amendments, repeals and revocations
  602. 347Transitional provisions and savings
  603. 347ATransitional provision in relation to EU exit
  604. 347BTransitional provision relating to the Windsor Framework
  605. 348Amendments to existing law
  606. 349Repeals and revocations
  607. Signature
  608. Schedule 1: Further provisions for classification of medicinal products
  609. Part 1: Descriptions of certain medicinal products to be available only on prescription
  610. 1Paragraph 1
  611. 2Paragraph 2
  612. Part 2: Descriptions of certain medicinal products to be available only from a pharmacy
  613. 3Paragraph 3
  614. 4Paragraph 4
  615. 5Paragraph 5
  616. Schedule 2: Supplementary provision relating to advisory bodies and expert advisory groups
  617. Part: Terms of appointment
  618. 1Paragraph 1
  619. 2Paragraph 2
  620. 3Paragraph 3
  621. 4Paragraph 4
  622. Part: Facilities and proceedings
  623. 5Paragraph 5
  624. 6Paragraph 6
  625. 7Paragraph 7
  626. Part: Payment and expenses
  627. 8Paragraph 8
  628. 9Paragraph 9
  629. 10Paragraph 10
  630. 11Paragraph 11
  631. Part: Status
  632. 12Paragraph 12
  633. Schedule 2AModifications of Commission Directive 2003/94/EC
  634. Schedule 3: Applications for licences under Part 3
  635. Part: Manufacturer's licences
  636. 1Paragraph 1
  637. Part: Manufacturer’s licences (MM)
  638. 1AParagraph 1A
  639. Part: Manufacturer’s licence (POC)
  640. 1BParagraph 1B
  641. Part: Manufacturers' licence relating to import
  642. 2Paragraph 2
  643. Part: Wholesale dealer's licences
  644. 3Paragraph 3
  645. Part: All licences
  646. 4Paragraph 4
  647. Schedule 4: Standard provisions of licences under Part 3
  648. Part 1: Manufacturer's licence relating to manufacture and assembly
  649. 1Paragraph 1
  650. 2Paragraph 2
  651. 3Paragraph 3
  652. 4Paragraph 4
  653. 5Paragraph 5
  654. 6Paragraph 6
  655. 7Paragraph 7
  656. 8Paragraph 8
  657. 9Paragraph 9
  658. 10Paragraph 10
  659. 11Paragraph 11
  660. 12Paragraph 12
  661. 13Paragraph 13
  662. 14Paragraph 14
  663. 14AParagraph 14A
  664. 14BParagraph 14B
  665. Part 1A: Manufacturer’s licence (MM)
  666. 14CParagraph 14C
  667. 14DParagraph 14D
  668. 14EParagraph 14E
  669. 14FParagraph 14F
  670. 14GParagraph 14G
  671. 14HParagraph 14H
  672. 14IParagraph 14I
  673. 14JParagraph 14J
  674. 14KParagraph 14K
  675. Part 1B: Manufacturer’s Licence (POC)
  676. 14LParagraph 14L
  677. 14MParagraph 14M
  678. 14NParagraph 14N
  679. 14OParagraph 14O
  680. 14PParagraph 14P
  681. 14QParagraph 14Q
  682. 14RParagraph 14R
  683. 14SParagraph 14S
  684. 14TParagraph 14T
  685. Part 2: Manufacturer's licence relating to the import of medicinal products from a state other than an EEA State / Country other than an Approved Country for Import
  686. 15Paragraph 15
  687. 15AParagraph 15A
  688. 16Paragraph 16
  689. 17Paragraph 17
  690. 18Paragraph 18
  691. 19Paragraph 19
  692. 20Paragraph 20
  693. 21Paragraph 21
  694. 22Paragraph 22
  695. 23Paragraph 23
  696. 23ZAParagraph 23ZA
  697. 23AParagraph 23A
  698. 23BParagraph 23B
  699. Part 3: Manufacturer's licence relating to exempt advanced therapy medicinal products
  700. 24Paragraph 24
  701. 25Paragraph 25
  702. 26Paragraph 26
  703. 27Paragraph 27
  704. Part 4: Wholesale dealer's licence
  705. All wholesale dealer's licences
  706. 28Paragraph 28
  707. 29Paragraph 29
  708. 30Paragraph 30
  709. 31Paragraph 31
  710. Wholesale dealer's licence relating to special medicinal products
  711. 32Paragraph 32
  712. 33Paragraph 33
  713. 33AParagraph 33A
  714. 34Paragraph 34
  715. 35Paragraph 35
  716. 36Paragraph 36
  717. 37Paragraph 37
  718. 38Paragraph 38
  719. 39Paragraph 39
  720. 40Paragraph 40
  721. 41Paragraph 41
  722. 41AParagraph 41A
  723. 42Paragraph 42
  724. Wholesale dealer's licence relating to exempt advanced therapy medicinal products
  725. 43Paragraph 43
  726. 44Paragraph 44
  727. Schedule 5: Review upon oral representations
  728. Part: Application of this Schedule
  729. 1Paragraph 1
  730. Part: Appointment of reviewers
  731. 2Paragraph 2
  732. Part: Procedure before hearing
  733. 3Paragraph 3
  734. Part: Procedure at hearing
  735. 4Paragraph 4
  736. Part: Procedure following hearing
  737. 5Paragraph 5
  738. Schedule 6: Manufacturer's and wholesale dealer's licences for exempt advanced therapy medicinal products
  739. Part 1: Manufacturer's licences
  740. 1Paragraph 1
  741. 2Paragraph 2
  742. 3Paragraph 3
  743. 4Paragraph 4
  744. 5Paragraph 5
  745. 6Paragraph 6
  746. 7Paragraph 7
  747. 8Paragraph 8
  748. 9Paragraph 9
  749. 10Paragraph 10
  750. 11Paragraph 11
  751. 12Paragraph 12
  752. Part 2: Wholesale dealer's licences
  753. 13Paragraph 13
  754. 14Paragraph 14
  755. 15Paragraph 15
  756. 16Paragraph 16
  757. 17Paragraph 17
  758. 18Paragraph 18
  759. 19Paragraph 19
  760. 20Paragraph 20
  761. Schedule 7: Qualified persons
  762. Part 1: Qualification requirements for qualified person
  763. 1Paragraph 1
  764. 2Paragraph 2
  765. 3Paragraph 3
  766. 4Paragraph 4
  767. 5Paragraph 5
  768. 6Paragraph 6
  769. 7Paragraph 7
  770. 8Paragraph 8
  771. Part 2: Qualified persons with long experience
  772. 9Paragraph 9
  773. 10Paragraph 10
  774. 11Paragraph 11
  775. Part 3: Obligations of qualified person
  776. 12Paragraph 12
  777. 12AParagraph 12A
  778. 12BParagraph 12B
  779. 13Paragraph 13
  780. 14Paragraph 14
  781. 15Paragraph 15
  782. Schedule 7A: Information to be provided for registration as an importer, manufacturer or distributor of active substances
  783. 1Paragraph 1
  784. 2Paragraph 2
  785. 3Paragraph 3
  786. 4Paragraph 4
  787. 5Paragraph 5
  788. 6Paragraph 6
  789. 7Paragraph 7
  790. 8Paragraph 8
  791. 9Paragraph 9
  792. 10Paragraph 10
  793. 11Paragraph 11
  794. 12Paragraph 12
  795. 13Paragraph 13
  796. 14Paragraph 14
  797. 15Paragraph 15
  798. 16Paragraph 16
  799. 17Paragraph 17
  800. 18Paragraph 18
  801. 19Paragraph 19
  802. 20Paragraph 20
  803. 21Paragraph 21
  804. 22Paragraph 22
  805. 23Paragraph 23
  806. 24Paragraph 24
  807. Schedule 8: Material to accompany an application for a UK marketing authorisation
  808. Part 1: General requirements
  809. 1Paragraph 1
  810. 2Paragraph 2
  811. 3Paragraph 3
  812. 4Paragraph 4
  813. 5Paragraph 5
  814. 6Paragraph 6
  815. 7Paragraph 7
  816. 8Paragraph 8
  817. 9Paragraph 9
  818. 9AParagraph 9A
  819. 10Paragraph 10
  820. 11Paragraph 11
  821. 12Paragraph 12
  822. 13Paragraph 13
  823. 14Paragraph 14
  824. 15Paragraph 15
  825. 16Paragraph 16
  826. 17Paragraph 17
  827. 18Paragraph 18
  828. 19Paragraph 19
  829. 20Paragraph 20
  830. 21Paragraph 21
  831. 22Paragraph 22
  832. 2Summary of the product characteristics
  833. 23Paragraph 23
  834. 24Paragraph 24
  835. 25Paragraph 25
  836. 25AParagraph 25A
  837. 26Paragraph 26
  838. 27Paragraph 27
  839. 28Paragraph 28
  840. 29Paragraph 29
  841. 30Paragraph 30
  842. 31Paragraph 31
  843. 32Paragraph 32
  844. 33Paragraph 33
  845. 34Paragraph 34
  846. 35Paragraph 35
  847. 36Paragraph 36
  848. Schedule 8A: Material to accompany an application for a parallel import licence
  849. 1Paragraph 1
  850. 2Paragraph 2
  851. 3Paragraph 3
  852. 4Paragraph 4
  853. 5Paragraph 5
  854. 6Paragraph 6
  855. 7Paragraph 7
  856. 8Paragraph 8
  857. 9Paragraph 9
  858. Schedule 8BModifications of Annex I to the 2001 Directive
  859. Schedule 8C: Material to accompany an application for a UK marketing authorisation under the unfettered access route
  860. 1Paragraph 1
  861. 2Paragraph 2
  862. 3Paragraph 3
  863. Schedule 9: Undertakings by non- United Kingdom manufacturers
  864. 1Paragraph 1
  865. 2Paragraph 2
  866. 3Paragraph 3
  867. 4Paragraph 4
  868. 5Paragraph 5
  869. 6Paragraph 6
  870. 7Paragraph 7
  871. 8Paragraph 8
  872. 9Paragraph 9
  873. 10Paragraph 10
  874. 11Paragraph 11
  875. 12Paragraph 12
  876. Schedule 9A: Meaning of terms used in the orphan criteria and in regulation 58D
  877. 1Prevalence of a condition in the United Kingdom
  878. 2Potential for return on investment
  879. 3Existence of other methods of diagnosis, prevention or treatment
  880. 4Increased safety or effectiveness and clinical superiority
  881. 5Paragraph 5
  882. 6Paragraph 6
  883. 7Paragraph 7
  884. 8Paragraph 8
  885. Schedule 10: National homoeopathic products
  886. Part: Meaning of “national homoeopathic product”
  887. 1Paragraph 1
  888. Part: General requirements for application
  889. 2Paragraph 2
  890. Part: Requirement to submit safety data
  891. 3Paragraph 3
  892. Part: Exceptions to requirement to submit safety data
  893. 4Paragraph 4
  894. Part: Requirement to submit efficacy data
  895. 5Paragraph 5
  896. Schedule 10A: Variations to a UK marketing authorisation
  897. 1Interpretation
  898. 2Classification of variations
  899. 3Licensing authority recommendation on unclassified variations
  900. 4Variations leading to the revision of product information
  901. 5Grouping of variations
  902. 6Notification procedure for minor variations of type IA
  903. 7Notification procedure for minor variations of type IB
  904. 8Prior approval procedure for major variations of type II
  905. 9Elements to be submitted
  906. 10Measures to close the procedures specified in paragraphs 6 to 8
  907. 11Extensions of marketing authorisations
  908. 12Human influenza vaccines
  909. 13Pandemic situation with respect to human influenza
  910. 14Urgent safety restrictions
  911. 15Amendments to the decision granting the marketing authorisation
  912. 16Implementation of variations
  913. 17Continuous monitoring
  914. Schedule 11: Advice and representations
  915. Part 1: General procedures
  916. Application of this Part
  917. 1Paragraph 1
  918. Requirement to consult the appropriate committee
  919. 2Paragraph 2
  920. Exceptions to requirement to consult
  921. 3Paragraph 3
  922. 4Paragraph 4
  923. Provisional opinion against authorisation
  924. 5Paragraph 5
  925. Opportunity to make representations
  926. 6Paragraph 6
  927. Written representations
  928. 7Paragraph 7
  929. Oral representations
  930. 8Paragraph 8
  931. Other decisions of the appropriate committee
  932. 9Paragraph 9
  933. Decision of licensing authority
  934. 10Paragraph 10
  935. Right to review after paragraph 10 notification
  936. 11Paragraph 11
  937. Licensing authority decisions in other cases
  938. 12Paragraph 12
  939. Right to review or representations after paragraph 12 notification
  940. 13Paragraph 13
  941. Part 1A: Paediatric Decisions
  942. 13AApplication of this Part
  943. 13BOpportunity to make representations
  944. 13CWritten representations
  945. 13DOral representations
  946. 13EOther decisions of the appropriate committee
  947. 13FDecision of licensing authority
  948. 13GRight to review after paragraph 13F notification
  949. Part 2: Type II variation applications, complex variation applications and new excipient variation applications
  950. Application of this Part
  951. 14Paragraph 14
  952. 15Paragraph 15
  953. 16Paragraph 16
  954. 17Paragraph 17
  955. Opportunity to make representations
  956. 18Paragraph 18
  957. Written representations
  958. 19Paragraph 19
  959. Oral representations
  960. 20Paragraph 20
  961. Other decisions of the appropriate committee
  962. 21Paragraph 21
  963. Decision of licensing authority following report
  964. 22Paragraph 22
  965. Right to review after paragraph 22 notification
  966. 23Paragraph 23
  967. Part 3: Referral to the appropriate committee for traditional herbal registrations
  968. Application of this Part
  969. 24Paragraph 24
  970. Opportunity to make representations
  971. 25Paragraph 25
  972. Written representations
  973. 26Paragraph 26
  974. Oral representations
  975. 27Paragraph 27
  976. Other decisions of the appropriate committee
  977. 28Paragraph 28
  978. Decision of licensing authority following report
  979. 29Paragraph 29
  980. Right to review after paragraph 29 notification
  981. 30Paragraph 30
  982. Part 4: Exceptions to Schedule
  983. 31Paragraph 31 Repealed
  984. 32Paragraph 32
  985. 33Paragraph 33
  986. 34Paragraph 34 Repealed
  987. 35Paragraph 35 Repealed
  988. 36Paragraph 36
  989. 37Paragraph 37 Repealed
  990. 38Paragraph 38 Repealed
  991. 39Paragraph 39
  992. Schedule 12: Material to accompany an application for a traditional herbal registration
  993. Part 1: General requirements
  994. 1Paragraph 1
  995. 2Paragraph 2
  996. 3Paragraph 3
  997. 4Paragraph 4
  998. 5Paragraph 5
  999. 6Paragraph 6
  1000. 7Paragraph 7
  1001. 8Paragraph 8
  1002. 9Paragraph 9
  1003. 10Paragraph 10
  1004. 11Paragraph 11
  1005. 12Paragraph 12
  1006. 13Paragraph 13
  1007. 14Paragraph 14
  1008. 15Paragraph 15
  1009. 16Paragraph 16
  1010. 17Paragraph 17
  1011. 18Paragraph 18
  1012. 19Paragraph 19
  1013. 20Paragraph 20
  1014. 2Summary of the product characteristics
  1015. 21Paragraph 21
  1016. 22Paragraph 22
  1017. 23Paragraph 23
  1018. 24Paragraph 24
  1019. 25Paragraph 25
  1020. 26Paragraph 26
  1021. 27Paragraph 27
  1022. 28Paragraph 28
  1023. 29Paragraph 29
  1024. 30Paragraph 30
  1025. Schedule 12A: Further provision as to the performance of pharmacovigilance activities
  1026. Part 1: Pharmacovigilance system master file
  1027. 1Structure of the pharmacovigilance system master file
  1028. 2Content of the pharmacovigilance system master file
  1029. 3Content of the Annex to the pharmacovigilance system master file
  1030. 4Maintenance of the pharmacovigilance system master file
  1031. 5Form of the documents contained in the pharmacovigilance system master file
  1032. 6Subcontracting
  1033. 7Availability and location of the pharmacovigilance system master file
  1034. Part 2: Minimum requirements for the quality systems for the performance of pharmacovigilance activities by the licensing authority and holders
  1035. 8Quality system
  1036. 9Performance indicators
  1037. Part 3: Minimum requirements for the quality systems for the performance of pharmacovigilance activities by holders
  1038. 10Management of human resources
  1039. 11Compliance management
  1040. 12Record management and data retention
  1041. 13Audit
  1042. Part 4: Minimum requirements for the quality systems for the performance of pharmacovigilance activities by the licensing authority
  1043. 14Management of human resources
  1044. 15Compliance management
  1045. 16Record management and data retention
  1046. 17Audit
  1047. Part 5: Use of terminology, formats and standards
  1048. 18Use of internationally agreed terminology, formats and standards
  1049. Part 6: Transmission of reports of suspected adverse reactions
  1050. 19Individual case safety reports
  1051. 20Content of the individual case safety report
  1052. 21Format of electronic transmission of suspected adverse reactions
  1053. Part 7: Risk management plans
  1054. 22Content of the risk management plan
  1055. 23Summary of the risk management plan
  1056. 24Updates of the risk management plan
  1057. 25Format of the risk management plan
  1058. Part 8: Periodic safety update reports
  1059. 26Content of periodic safety update reports
  1060. 27Format of periodic safety update reports
  1061. Part 9: Post-authorisation safety studies
  1062. 28Scope and interpretation
  1063. 29Obligations as to post-authorisation safety studies
  1064. 30Format of the study protocol
  1065. 31Format of the abstract of the final study report
  1066. 32Format of the final study report
  1067. Schedule 13: Prescription only medicines for which community practitioner nurse prescribers are appropriate practitioners
  1068. Paragraph
  1069. Schedule 14: Prescription etc by supplementary prescribers: particulars of clinical management plan
  1070. Paragraph
  1071. Schedule 15: Requirements for specific products subject to general sale
  1072. 1Paragraph 1
  1073. 2Paragraph 2
  1074. Schedule 16: Patient group directions and vaccine group directions
  1075. Part 1: Particulars to be included in a patient group direction and a vaccine group direction
  1076. 1Paragraph 1
  1077. 2Paragraph 2
  1078. 3Paragraph 3
  1079. 4Paragraph 4
  1080. 5Paragraph 5
  1081. 6Paragraph 6
  1082. 7Paragraph 7
  1083. 8Paragraph 8
  1084. 9Paragraph 9
  1085. 10Paragraph 10
  1086. 11Paragraph 11
  1087. 12Paragraph 12
  1088. 13Paragraph 13
  1089. 14Paragraph 14
  1090. 15Paragraph 15
  1091. 16Paragraph 16
  1092. 17Paragraph 17
  1093. 2Persons on whose behalf a patient group Direction must be signed
  1094. 3Persons by whom or on whose behalf a patient group direction used as described in regulation 234 must be signed
  1095. Part 4: Classes of individuals by whom supplies may be made
  1096. Paragraph
  1097. Schedule 17: Exemption for sale, supply or administration by certain persons
  1098. 1Exemption from restrictions on sale and supply of prescription only medicines
  1099. 2Exemption from the restriction on supply of prescription only medicines
  1100. 3Exemptions from the restriction on administration of prescription only medicines
  1101. 4Exemptions from the restrictions in regulations 220 and 221 for certain persons who sell, supply, or offer for sale or supply certain medicinal products
  1102. 5Exemptions from the restrictions in regulations 220 and 221 for certain persons who supply certain medicinal products
  1103. Schedule 18: Substances that may not be sold or supplied by a pharmacist without a prescription in reliance on regulation 225
  1104. Paragraph
  1105. Schedule 19: Medicinal products for parenteral administration in an emergency
  1106. Paragraph
  1107. Schedule 20: Herbal medicinal products specified for the purposes of regulation 241
  1108. 1Part 1
  1109. 2Part 2
  1110. Schedule 21: Medicinal products at high dilutions
  1111. Part 1: Dilutions of unit preparations diluted to at least one part in a thousand (3x)
  1112. Paragraph
  1113. Part 2: Dilutions of unit preparations diluted to at least one part in a million (6x)
  1114. Paragraph
  1115. Part 3: Dilutions of unit preparations diluted to at least one part in ten (1x)
  1116. Paragraph
  1117. Part 4: Dilutions of unit preparations diluted to at least one part in ten (1x) for external use
  1118. Paragraph
  1119. Schedule 22Classes of person for the purposes of regulation 249
  1120. Schedule 23: Particulars in pharmacy records
  1121. 1Paragraph 1
  1122. 2Paragraph 2
  1123. 3Paragraph 3
  1124. 4Paragraph 4
  1125. 5Paragraph 5
  1126. 6Paragraph 6
  1127. Schedule 24: Packaging information requirements
  1128. Part 1: Outer and immediate packaging
  1129. 1Paragraph 1
  1130. 2Paragraph 2
  1131. 3Paragraph 3
  1132. 4Paragraph 4
  1133. 5Paragraph 5
  1134. 6Paragraph 6
  1135. 7Paragraph 7
  1136. 8Paragraph 8
  1137. 9Paragraph 9
  1138. 10Paragraph 10
  1139. 11Paragraph 11
  1140. 12Paragraph 12
  1141. 13Paragraph 13
  1142. 14Paragraph 14
  1143. 15Paragraph 15
  1144. 16Paragraph 16
  1145. 17Paragraph 17
  1146. 18Paragraph 18
  1147. 18AParagraph 18A Repealed
  1148. 18BParagraph 18B
  1149. Part 2: Immediate packaging: blister packs
  1150. 19Paragraph 19
  1151. 20Paragraph 20
  1152. 21Paragraph 21
  1153. 22Paragraph 22
  1154. 23Paragraph 23
  1155. 24Paragraph 24
  1156. 25Paragraph 25
  1157. Part 3: Immediate packaging: small packages
  1158. 26Paragraph 26
  1159. 27Paragraph 27
  1160. 28Paragraph 28
  1161. 29Paragraph 29
  1162. 30Paragraph 30
  1163. 31Paragraph 31
  1164. 32Paragraph 32
  1165. 33Paragraph 33
  1166. Part 4: Outer and immediate packaging: advanced therapy medicinal products ...
  1167. 34Paragraph 34
  1168. 35Paragraph 35
  1169. 36Paragraph 36
  1170. 37Paragraph 37
  1171. 38Paragraph 38
  1172. 39Paragraph 39
  1173. 40Paragraph 40
  1174. 41Paragraph 41
  1175. 42Paragraph 42
  1176. 43Paragraph 43
  1177. 44Paragraph 44
  1178. 45Paragraph 45
  1179. 46Paragraph 46
  1180. 47Paragraph 47
  1181. 48Paragraph 48
  1182. 49Paragraph 49
  1183. 50Paragraph 50
  1184. Part 5: Immediate packaging: blister packs and small packaging (advanced therapy medicinal products ...)
  1185. 51Paragraph 51
  1186. 52Paragraph 52
  1187. 53Paragraph 53
  1188. Part 6: Outer and Immediate Packaging: POC Medicinal Products for sale or supply in Great Britain only
  1189. 54Paragraph 54
  1190. 55Paragraph 55
  1191. 56Paragraph 56
  1192. 57Paragraph 57
  1193. 58Paragraph 58
  1194. 59Paragraph 59
  1195. 60Paragraph 60
  1196. 61Paragraph 61
  1197. 62Paragraph 62
  1198. 63Paragraph 63
  1199. 64Paragraph 64
  1200. 65Paragraph 65
  1201. 66Paragraph 66
  1202. 67Paragraph 67
  1203. 68Paragraph 68
  1204. 69Paragraph 69
  1205. 70Paragraph 70
  1206. Part 7: Immediate Packaging: Blister Packs and Small Packaging (POC Medicinal Products for sale or supply in Great Britain only)
  1207. 71Paragraph 71
  1208. 72Paragraph 72
  1209. 73Paragraph 73
  1210. 74Paragraph 74
  1211. 75Paragraph 75
  1212. 76Paragraph 76
  1213. 77Paragraph 77
  1214. 78Paragraph 78
  1215. 79Paragraph 79
  1216. 80Paragraph 80
  1217. Schedule 25: Packaging requirements: specific provisions
  1218. Part 1: Medicines on prescription
  1219. 1Paragraph 1
  1220. 2Paragraph 2
  1221. 3Paragraph 3
  1222. 4Paragraph 4
  1223. 5Paragraph 5
  1224. 6Paragraph 6
  1225. 6AParagraph 6A
  1226. Part 2: Transport, delivery and storage
  1227. 7Paragraph 7
  1228. 8Paragraph 8
  1229. 9Paragraph 9
  1230. Part 3: Pharmacy and prescription only medicines
  1231. 10Paragraph 10
  1232. 11Paragraph 11
  1233. 12Paragraph 12
  1234. 13Paragraph 13
  1235. Part 4: Medicines containing paracetamol
  1236. 14Paragraph 14
  1237. 15Paragraph 15
  1238. 16Paragraph 16
  1239. 17Paragraph 17
  1240. 18Paragraph 18
  1241. Schedule 26: Packaging requirements: special provisions
  1242. Part 1: Supply by doctors, dentists, nurses, midwives and pharmacists
  1243. 1Paragraph 1
  1244. 2Paragraph 2
  1245. 3Paragraph 3
  1246. 4Paragraph 4
  1247. 4AParagraph 4A
  1248. Part 2: Pharmacy exceptions
  1249. 5Paragraph 5
  1250. 6Paragraph 6
  1251. 7Paragraph 7
  1252. 8Paragraph 8
  1253. 9Paragraph 9
  1254. 10Paragraph 10
  1255. 10AParagraph 10A
  1256. 11Paragraph 11
  1257. Schedule 27: Package leaflets
  1258. Part 1: General requirements
  1259. 1Paragraph 1
  1260. 2Paragraph 2
  1261. 3Paragraph 3
  1262. 4Paragraph 4
  1263. 5Paragraph 5
  1264. 6Paragraph 6
  1265. 7Paragraph 7
  1266. 8Paragraph 8
  1267. 9Paragraph 9
  1268. 10Paragraph 10
  1269. 11Paragraph 11
  1270. 12Paragraph 12
  1271. 13Paragraph 13
  1272. 14Paragraph 14
  1273. 15Paragraph 15
  1274. Part 2: Paracetamol
  1275. 16Paragraph 16
  1276. 17Paragraph 17
  1277. Part 3: Advanced therapy medicinal products ...
  1278. 18Paragraph 18
  1279. 19Paragraph 19
  1280. 20Paragraph 20
  1281. 21Paragraph 21
  1282. 22Paragraph 22
  1283. 23Paragraph 23
  1284. 24Paragraph 24
  1285. 25Paragraph 25
  1286. 26Paragraph 26
  1287. 27Paragraph 27
  1288. 28Paragraph 28
  1289. 29Paragraph 29
  1290. 30Paragraph 30
  1291. Schedule 28: Labelling requirements for registrable homoeopathic medicinal products
  1292. Part 1: Outer and immediate packaging
  1293. 1Paragraph 1
  1294. 2Paragraph 2
  1295. 3Paragraph 3
  1296. 4Paragraph 4
  1297. 5Paragraph 5
  1298. 6Paragraph 6
  1299. 7Paragraph 7
  1300. 8Paragraph 8
  1301. 9Paragraph 9
  1302. 10Paragraph 10
  1303. 11Paragraph 11
  1304. 12Paragraph 12
  1305. Part 2: Blister packs etc contained in outer packaging
  1306. 13Paragraph 13
  1307. 14Paragraph 14
  1308. 15Paragraph 15
  1309. 16Paragraph 16
  1310. 17Paragraph 17
  1311. Part 3: Small immediate packaging
  1312. 18Paragraph 18
  1313. 19Paragraph 19
  1314. 20Paragraph 20
  1315. 21Paragraph 21
  1316. 22Paragraph 22
  1317. 23Paragraph 23
  1318. 24Paragraph 24
  1319. Schedule 29: Labelling of traditional herbal medicinal products
  1320. Part 1: Traditional herbal medicinal products: general
  1321. 1Paragraph 1
  1322. 2Paragraph 2
  1323. Part 2: Traditional herbal medicinal products not subject to general sale
  1324. 3Paragraph 3
  1325. 4Paragraph 4
  1326. Schedule 30: Particulars for advertisements to persons qualified to prescribe or supply
  1327. 1Paragraph 1
  1328. 2Paragraph 2
  1329. 2AParagraph 2A
  1330. 3Paragraph 3
  1331. 4Paragraph 4
  1332. 5Paragraph 5
  1333. 6Paragraph 6
  1334. 7Paragraph 7
  1335. 8Paragraph 8
  1336. 9Paragraph 9
  1337. Schedule 31: Sampling
  1338. Part: Introductory
  1339. 1Paragraph 1
  1340. Part: Division of sample
  1341. 2Paragraph 2
  1342. 3Paragraph 3
  1343. 4Paragraph 4
  1344. 5Paragraph 5
  1345. 6Paragraph 6
  1346. 7Paragraph 7
  1347. 8Paragraph 8
  1348. 9Paragraph 9
  1349. 10Paragraph 10
  1350. 11Paragraph 11
  1351. 12Paragraph 12
  1352. 13Paragraph 13
  1353. Part: Notice to person named on container
  1354. 14Paragraph 14
  1355. Part: Analysis or other examination
  1356. 15Paragraph 15
  1357. 16Paragraph 16
  1358. 17Paragraph 17
  1359. 18Paragraph 18
  1360. 19Paragraph 19
  1361. 20Paragraph 20
  1362. Part: Provisions as to evidence
  1363. 21Paragraph 21
  1364. 22Paragraph 22
  1365. 23Paragraph 23
  1366. Part: Analysis under direction of court
  1367. 24Paragraph 24
  1368. 25Paragraph 25
  1369. Part: Proof by written statement
  1370. 26Paragraph 26
  1371. Part: Payment for sample taken under compulsory powers
  1372. 27Paragraph 27
  1373. Schedule 32: Transitional provisions and savings
  1374. Part: Continuity of the law
  1375. 1Paragraph 1
  1376. Part: Product licences
  1377. 2Paragraph 2
  1378. Part: Product licences of right
  1379. 3Paragraph 3
  1380. Part: Classification of UK marketing authorisation and certificate of registration
  1381. 4Paragraph 4
  1382. Part: Advanced therapy medicinal products
  1383. 5Paragraph 5
  1384. Part: Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010 (S.I. 2010/1882)
  1385. 6Paragraph 6
  1386. Part: Section 60 of the Medicines Act 1968 etc
  1387. 7Paragraph 7
  1388. Schedule 33: Transitional arrangements: pharmacovigilance
  1389. 1Pharmacovigilance system master file Repealed
  1390. 2Paragraph 2 Repealed
  1391. 3Post-authorisation safety studies
  1392. 4Paragraph 4
  1393. 5Reporting obligations Repealed
  1394. 6Paragraph 6 Repealed
  1395. 7Paragraph 7 Repealed
  1396. 8Paragraph 8 Repealed
  1397. 9Periodic safety update reports Repealed
  1398. 10Paragraph 10 Repealed
  1399. Schedule 33A: Transitional provision in relation to EU Exit
  1400. Part 1: Interpretation
  1401. 1Paragraph 1
  1402. Part 2: Manufacturing, wholesale dealing and brokering
  1403. 2Wholesale dealer's licence used to distribute a medicinal product imported from an EEA State before IP completion day
  1404. 3Approved country for import list on IP completion day (regulation 18A)
  1405. 4Qualified persons and approved country for batch testing list on IP completion day (Schedule 7)
  1406. 5List of countries with equivalent regulatory standards as to the manufacturing of active substances on IP completion day (regulation 45O(6) to (9))
  1407. Part 3: Transitional provision in respect of conversion of EU marketing authorisations in force immediately before IP completion day
  1408. 6Conversion of EU marketing authorisations in force before IP completion day
  1409. 7Classification of converted EU marketing authorisations
  1410. 8Obligations of licensing authority in connection with converted EU marketing authorisations
  1411. 9Obligations of holders of converted EU marketing authorisations
  1412. 10Powers of licensing authority in connection with provision of information
  1413. 11Variations of converted EU marketing authorisations notified or applied for before IP completion day
  1414. 12Variations of converted EU marketing authorisations submitted to EMA after IP completion day but before the data submission date
  1415. 13Variations of converted EU marketing authorisations sought in advance of the data submission date
  1416. 14Applications for renewals of converted EU marketing authorisations made before IP completion day
  1417. 15Applications for renewals of conditional marketing authorisations made before IP completion day
  1418. 16Applications for renewals of converted EU marketing authorisations made after IP completion day
  1419. 17Applications for renewals of conditional marketing authorisations made after IP completion day
  1420. 18Renewals of converted EU marketing authorisations sought in advance of the data submission date
  1421. 19Article 61(3) notifications made before IP completion day in relation to converted EU marketing authorisations
  1422. 20Article 61(3) notifications made in relation to converted EU marketing authorisations after IP completion day but before the data submission date
  1423. 21Article 61(3) notifications sought in advance of the data submission date
  1424. 22Place of establishment for converted EU marketing authorisation holder established in EEA state before IP completion day
  1425. 23Temporary exemption as to packaging requirements for converted EU marketing authorisations
  1426. 24Referrals made under Article 20 of Regulation (EC) No 726/2004 that have not concluded or been implemented before IP completion day
  1427. 25Enforcement
  1428. Part 4: Transitional provision in respect of UK marketing authorisations, parallel import licences and parallel distribution notices
  1429. 26ZAStatus of certain UK marketing authorisations granted before IP completion day
  1430. 26Place of establishment for UK marketing authorisation holder or parallel import licence holder established in an EEA State before IP completion day
  1431. 27Temporary exemption as to packaging requirements: change of place of establishment
  1432. 27AStatus of parallel import licences granted before IP completion day
  1433. 28Conversion of parallel distribution notices in to parallel import licences
  1434. 29Inclusion of the batch testing condition in relevant UK marketing authorisations, and batch testing of biological medicinal products in the EEA before IP completion day (regulation 60A)
  1435. 29AApplication of the batch testing requirement to relevant EU marketing authorisations, and batch testing of biological medicinal products in the EEA before IP completion day (regulation 60B) Repealed
  1436. 30Existing data and marketing exclusivity and global marketing authorisations
  1437. 31Applications for EU marketing authorisations made before IP completion day
  1438. 32Place of establishment for UK marketing authorisation holder established in EEA state before IP completion day (pre-exit EU marketing authorisation applications)
  1439. 33Packaging in relation to UK marketing authorisations granted in response to application for EU marketing authorisation made before IP completion day
  1440. 34Applications made for a UK marketing authorisation before IP completion day to which Chapter 4 of Title III of the 2001 Directive applied
  1441. 35Transitional provision in respect of Plasma Master Files
  1442. 36Suspensions of UK marketing authorisations that have effect immediately before IP completion day that were imposed under Chapter 4 of Title III of the 2001 Directive or Regulation (EC) No 726/2004
  1443. 37Referrals made under Article 31 of the 2001 Directive concerning the suspension, variation or revocation of an EU marketing authorisation or a UK marketing authorisation that have not concluded before IP completion day
  1444. Part 5: Transitional provision in relation to variations of marketing authorisations other than converted EU marketing authorisations
  1445. 38Application or notification made before IP completion day in respect of a variation under Chapter IIa of Regulation (EC) No 1234/2008 (variations to purely national marketing authorisations)
  1446. 39Application or notification made before IP completion day in respect of a variation under Chapter II of Regulation (EC) No 1234/2008 (variations to marketing authorisations granted in accordance with Chapter 4 of the 2001 Directive)
  1447. 40Application or notification in respect of a variations made before IP completion day under Article 20 of Regulation (EC) No 1234/2008 (work-sharing procedure)
  1448. Part 6: Transitional provision in relation to the Paediatric Regulation
  1449. 41Transitional provision in relation to applications made to EMA before IP completion day under the Paediatric Regulation
  1450. 41ATransitional provision in relation to global marketing authorisations under the 2001 Directive
  1451. Part 8: Transitional provision in respect of homoeopathic medicinal products
  1452. 43List of countries for the purposes of the definition of “homoeopathic medicinal product” on IP completion day
  1453. 44Place of establishment for holders of certificates of registration established in EEA before IP completion day
  1454. 45Temporary exemption as to packaging requirements: change of place of establishment
  1455. 46Applications made for a certificate of registration for a registrable homoeopathic product before IP completion day to which Chapter 4 of Title III of the 2001 Directive applied
  1456. 47Suspensions of certificates of registration that have effect immediately before IP completion day that were imposed under Chapter 4 of Title III of the 2001 Directive
  1457. 48Referrals made under Article 31 of the 2001 Directive concerning the suspension, variation or revocation of a certificate of registration that have not concluded before IP completion day
  1458. Part 9: Transitional provision in respect of traditional herbal registrations
  1459. 49Place of establishment for holders of traditional herbal registrations established in EEA before IP completion day
  1460. 50Temporary exemption as to packaging requirements: change of place of establishment
  1461. 51List of approved countries for traditional use of a herbal medicinal product on IP completion day
  1462. 52Applications made for a traditional herbal registration before IP completion day to which Chapter 4 of Title III of the 2001 Directive applied
  1463. 53Suspensions of traditional herbal registrations that have effect immediately before IP completion day that were imposed under Chapter 4 of Title III of the 2001 Directive
  1464. 54Referrals made under Article 31 of the 2001 Directive concerning the suspension, variation or revocation of a traditional herbal registration that have not concluded before IP completion day
  1465. 55Proposals to refer an application for a traditional herbal registration to the Committee for Herbal Medicinal Products and the procedure in Part 3 of Schedule 11 that were on-going at IP completion day
  1466. Part 10: Transitional provision in respect of pharmacovigilance
  1467. 58Referrals made under Article 107i of the 2001 Directive concerning the evaluation of data from pharmacovigilance activities which are not concluded before IP completion day
  1468. 59Matters on-going at IP completion day in respect of periodic safety update reports
  1469. 60Matters on-going at IP completion day in relation to draft study protocols under Article 107n and 107o of the 2001 Directive (submission of, and amendment to, draft study protocols for required studies)
  1470. 61Matters on-going at IP completion day in respect of the follow up of final study reports
  1471. Part 11: Transitional provision in respect of Part 12
  1472. 62Approved country health professional list on IP completion day (regulation 214(6A))
  1473. Part 12: General provision in relation to transitional provisions
  1474. 63Licensing authority power to require information
  1475. Schedule 33B: Transitional Provision in relation to the Windsor Framework
  1476. 1Existing marketing authorisations
  1477. 2Existing applications for marketing authorisation
  1478. 3Post-authorisation processes
  1479. Schedule 34: Amendments to existing law
  1480. Part 1: The Medicines Acts 1968 and 1971
  1481. 1Paragraph 1
  1482. 2Paragraph 2
  1483. 3Paragraph 3
  1484. 4Paragraph 4
  1485. 5Paragraph 5
  1486. 6Paragraph 6
  1487. 7Paragraph 7
  1488. 8Paragraph 8
  1489. 9Paragraph 9
  1490. 10Paragraph 10
  1491. 11Paragraph 11
  1492. 12Paragraph 12
  1493. 13Paragraph 13
  1494. 14Paragraph 14
  1495. 15Paragraph 15
  1496. 16Paragraph 16
  1497. 17Paragraph 17
  1498. 18Paragraph 18
  1499. 19Paragraph 19
  1500. 20Paragraph 20
  1501. 21Paragraph 21
  1502. 22Paragraph 22
  1503. 23Paragraph 23
  1504. 24Paragraph 24
  1505. 25Paragraph 25
  1506. 26Paragraph 26
  1507. 27Paragraph 27
  1508. 28Paragraph 28
  1509. 29Paragraph 29
  1510. 30Paragraph 30
  1511. 31Paragraph 31
  1512. 32Paragraph 32
  1513. 33Paragraph 33
  1514. 34Paragraph 34
  1515. 35Paragraph 35
  1516. Medicines Act 1971
  1517. 36Paragraph 36
  1518. Part 2: Other primary legislation
  1519. Trade Descriptions Act 1968
  1520. 37Paragraph 37
  1521. House of Commons Disqualification Act 1975
  1522. 38Paragraph 38
  1523. Northern Ireland Assembly Disqualification Act 1975
  1524. 39Paragraph 39
  1525. Consumer Protection Act 1987
  1526. 40Paragraph 40
  1527. Environmental Protection Act 1990
  1528. 41Paragraph 41
  1529. Value Added Tax Act 1994
  1530. 42Paragraph 42
  1531. Health Act 1999
  1532. 43Paragraph 43
  1533. Communications Act 2003
  1534. 44Paragraph 44
  1535. Christmas Day and New Year's Day Trading (Scotland) Act 2007
  1536. 45Paragraph 45
  1537. Part 3: Northern Ireland Orders in Council
  1538. Health and Personal Social Services (Northern Ireland) Order 1972
  1539. 46Paragraph 46
  1540. Pharmacy (Northern Ireland) Order 1976
  1541. 47Paragraph 47
  1542. Poisons (Northern Ireland) Order 1976
  1543. 48Paragraph 48
  1544. Diseases of Animals (Northern Ireland) Order 1981
  1545. 49Paragraph 49
  1546. Waste and Contaminated Land (Northern Ireland) Order 1997
  1547. 50Paragraph 50
  1548. Shops (Sunday Trading &c.) (Northern Ireland) Order 1997
  1549. 51Paragraph 51
  1550. Part 4: The Medicines for Human Use (Clinical Trials) Regulations 2004
  1551. 52Paragraph 52
  1552. 53Paragraph 53
  1553. 54Paragraph 54
  1554. 55Paragraph 55
  1555. 56Paragraph 56
  1556. 57Paragraph 57
  1557. 58Paragraph 58
  1558. 59Paragraph 59
  1559. 60Paragraph 60
  1560. 61Paragraph 61
  1561. 62Paragraph 62
  1562. 63Paragraph 63
  1563. 64Paragraph 64
  1564. Part 5: Other United Kingdom, Scotland and Wales Secondary legislation
  1565. Medicines (Administration of Radioactive Substances) Regulations 1978
  1566. 65Paragraph 65
  1567. Importation of Animal Products and Poultry Products Order 1980
  1568. 66Paragraph 66
  1569. Medicines Act (Hearings by Persons Appointed) (Scotland) Rules 1986
  1570. 67Paragraph 67
  1571. Medicines Act (Hearings by Persons Appointed) Rules 1986
  1572. 68Paragraph 68
  1573. Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Order 1989
  1574. 69Paragraph 69
  1575. Medical Devices (Consultation Requirements) (Fees) Regulations 1995
  1576. 70Paragraph 70
  1577. Prescription Only Medicines (Human Use) Order 1997
  1578. 71Paragraph 71
  1579. General Optical Council (Rules relating to Injury or Disease of the Eye) Order of Council 1999
  1580. 72Paragraph 72
  1581. National Health Service (Charges for Drugs and Appliances) Regulations 2000
  1582. 73Paragraph 73
  1583. Biocidal Products Regulations 2001
  1584. 74Paragraph 74
  1585. Medicines (Aristolochia and Mu Tong etc) (Prohibition Order) 2001
  1586. 75Paragraph 75
  1587. Misuse of Drugs Regulations 2001
  1588. 76Paragraph 76
  1589. Medicines for Human Use (Kava-kava) (Prohibition Order) 2002
  1590. 77Paragraph 77
  1591. Medicines and Healthcare Products Regulatory Agency Trading Fund Order 2003
  1592. 78Paragraph 78 Repealed
  1593. Enterprise Act 2002 (Part 8 Community Infringements Specified UK Laws) Order 2003
  1594. 79Paragraph 79
  1595. Enterprise Act 2002 (Part 8 Notice to OFT of Intended Prosecution Specified Enactments, Revocation and Transitional Provision) Order 2003
  1596. 80Paragraph 80
  1597. Health Professions (Parts of and Entries in the Register) Order of Council 2003
  1598. 81Paragraph 81
  1599. Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003
  1600. 82Paragraph 82
  1601. National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004
  1602. 83Paragraph 83
  1603. National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2004
  1604. 84Paragraph 84
  1605. National Health Service (General Medical Services Contracts) Regulations 2004
  1606. 85Paragraph 85 Repealed
  1607. National Health Service (General Medical Services Contracts) (Wales) Regulations 2004
  1608. 86Paragraph 86
  1609. National Health Service (Personal Medical Services Agreements) Regulations 2004
  1610. 87Paragraph 87 Repealed
  1611. National Health Service (General Medical Services Contracts) (Prescription of Drugs Etc.) (Wales) Regulations 2004
  1612. 88Paragraph 88
  1613. Contracting Out (Functions relating to Broadcast Advertising) and Specification of Relevant Functions Order 2004
  1614. 89Paragraph 89
  1615. General Optical Council (Registration Rules) Order of Council 2005
  1616. 90Paragraph 90
  1617. National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) Regulations 2007
  1618. 91Paragraph 91
  1619. Human Tissue (Quality and Safety for Human Application) Regulations 2007
  1620. 92Paragraph 92
  1621. Legislative and Regulatory Reform (Regulatory Functions) Order 2007
  1622. 93Paragraph 93
  1623. Medicines for Human Use (Prohibition) (Senecio and Miscellaneous Amendments) Order 2008
  1624. 94Paragraph 94
  1625. Specified Animal Pathogens Order 2008
  1626. 95Paragraph 95
  1627. Specified Animal Pathogens (Wales) Order 2008
  1628. 96Paragraph 96
  1629. Health Service Branded Medicines (Control of Prices and Supply of Information) (No 2) Regulations 2008
  1630. 97Paragraph 97
  1631. Specified Animal Pathogens (Scotland) Order 2009
  1632. 98Paragraph 98
  1633. National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009
  1634. 99Paragraph 99
  1635. Co-ordination of Regulatory Enforcement (Regulatory Functions in Scotland and Northern Ireland) Order 2009
  1636. 100Paragraph 100
  1637. Single Use Carrier Bags Charge (Wales) Regulations 2010
  1638. 101Paragraph 101
  1639. Part 6: Northern Ireland statutory rules
  1640. Control of Pesticides Regulations (Northern Ireland) 1987
  1641. 102Paragraph 102
  1642. Prison and Young Offenders Centre (Amendment) Rules (Northern Ireland) 1995
  1643. 103Paragraph 103
  1644. Diseases of Animals (Importation of Bird Products) Order (Northern Ireland) 1996
  1645. 104Paragraph 104
  1646. Pharmaceutical Services Regulations (Northern Ireland) 1997
  1647. 105Paragraph 105
  1648. Industrial Pollution Control (Prescribed Processes and Substances) Regulations (Northern Ireland) 1998
  1649. 106Paragraph 106
  1650. Products of Animal Origin (Import and Export) Regulations (Northern Ireland) 1998
  1651. 107Paragraph 107
  1652. Importation of Animal Pathogens Order (Northern Ireland) 1999
  1653. 108Paragraph 108
  1654. Biocidal Products Regulations (Northern Ireland) 2001
  1655. 109Paragraph 109
  1656. Misuse of Drugs Regulations (Northern Ireland) 2002
  1657. 110Paragraph 110
  1658. Control of Substances Hazardous to Health Regulations (Northern Ireland) 2003
  1659. 111Paragraph 111
  1660. Waste Management Licensing Regulations (Northern Ireland) 2003
  1661. 112Paragraph 112
  1662. Health and Personal Social Services (General Medical Services Contracts) Regulations (Northern Ireland) 2004
  1663. 113Paragraph 113
  1664. Nursing Homes Regulations (Northern Ireland) 2005
  1665. 114Paragraph 114
  1666. Residential Care Homes Regulations (Northern Ireland) 2005
  1667. 115Paragraph 115
  1668. Children's Homes Regulations (Northern Ireland) 2005
  1669. 116Paragraph 116
  1670. Healthy Start Scheme and Day Care Food Scheme Regulations (Northern Ireland) 2006
  1671. 117Paragraph 117
  1672. Avian Influenza and Influenza of Avian Origin in Mammals Regulations (Northern Ireland) 2007
  1673. 118Paragraph 118
  1674. Day Care Setting Regulations (Northern Ireland) 2007
  1675. 119Paragraph 119
  1676. Residential Family Centres Regulations (Northern Ireland) 2007
  1677. 120Paragraph 120
  1678. Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations (Northern Ireland) 2007
  1679. 121Paragraph 121
  1680. Specified Animal Pathogens Order (Northern Ireland) 2008
  1681. 122Paragraph 122
  1682. Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009
  1683. 123Paragraph 123
  1684. Private Water Supplies Regulations (Northern Ireland) 2009
  1685. 124Paragraph 124
  1686. Schedule 35Repeals and revocations
  1687. Explanatory note