OpenLegislation

The Human Medicines Regulations 2012 in Scotland

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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reg. 4AinsertedHuman Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) 2025 art. 5
reg. 8(1)words insertedHuman Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) 2025 art. 12(2)
reg. 167(2)(b)words insertedHuman Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) 2025 art. 12(6)
reg. 220AinsertedHuman Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) 2025 art. 7(3)
reg. 222A(4)words insertedHuman Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) 2025 art. 12(11)
reg. 274(2)(a)words insertedHuman Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) 2025 art. 12(15)
reg. 346(2)(c)(xxviiieza)insertedHuman Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) 2025 art. 12(16)(a)
Sch. 25 para. 6Awords insertedHuman Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) 2025 art. 12(17)
Sch. 26 para. 10Awords insertedHuman Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) 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. 217COriginal pack dispensing: medicinal products containing a relevant substance
  388. 218Requirements for prescriptions: approved country health professional
  389. 219Electronic prescriptions
  390. 219AElectronic Prescriptions: approved country health professionals
  391. Medicines not subject to general sale
  392. 220Sale or supply of medicinal products not subject to general sale
  393. General sale medicines
  394. 220BSale or supply of items dispensed by a pharmacist who is absent or treated as absent
  395. 221Sale or supply of medicinal products subject to general sale
  396. 222Sale of medicinal products from automatic machines
  397. 222AAssembly or part-assembly as part of “hub and spoke” dispensing arrangements between different businesses
  398. 222BHub and spoke arrangements: sharing of data between different businesses
  399. Chapter 3: Exemptions
  400. Exemptions relating to supply in specific circumstances
  401. 223Exemptions for doctors and dentists etc
  402. 224Emergency sale etc by pharmacist: prescriber unable to provide prescription
  403. 225Emergency sale etc by pharmacist: at patient's request
  404. 226Emergency sale etc by pharmacist: pandemic diseases
  405. 226ASale etc by a pharmacist in accordance with a serious shortage protocol
  406. 227Exemption for sale or supply in hospitals
  407. 228Exemptions relating to prescriptions given by certain health professionals
  408. 229Exemption for supply by national health service bodies and local authorities
  409. 230Exemption for supply etc under a PGD to assist doctors or dentists
  410. 231Exemption for supply etc under a PGD by independent hospitals etc
  411. 232Exemption for supply etc under a PGD by dental practices and clinics: England and Wales
  412. 233Exemption for supply etc under a PGD by person conducting a retail pharmacy business
  413. 234Exemption for supply etc of products under a PGD to assist the police etc
  414. 235Exemption for sale, supply or administration by certain persons
  415. 235AExemption for supply or administration of certain medicines used for vaccination
  416. Exemptions in relation to specific kinds of product
  417. 236Products consisting of or containing aloxiprin, aspirin or paracetamol
  418. 237Products consisting of or containing pseudoephedrine salts or ephedrine base or salts
  419. 237AAppropriate suppliers of naloxone products
  420. 238Administration of certain medicines in an emergency
  421. 239Administration of smallpox vaccine
  422. 240Radioactive medicinal products
  423. 241Exemptions in respect of certain herbal remedies
  424. 242Exemption for medicinal products at high dilution
  425. 243Exemption for certain homoeopathic medicinal products
  426. Other exemptions
  427. 244Exemption in cases involving another's default
  428. 245Exemption in case of forged prescription
  429. 246Exemption where requirements for prescriptions not met
  430. 247Exemption for supply in the event or anticipation of pandemic disease
  431. 247AProtocols relating to coronavirus and influenza vaccinations and immunisations Repealed
  432. 248Exemption for certain collection and delivery arrangements
  433. Chapter 4: Miscellaneous provisions, offences and disqualification
  434. Miscellaneous provisions
  435. 249Restrictions on persons to be supplied with medicinal products
  436. 250Exceptions to regulation 249
  437. 251Compliance with standards specified in certain publications
  438. 252Compliance with standards specified in certain publications: supplementary
  439. 253Pharmacy records
  440. 254Prohibitions concerning traceability of treatment with advanced therapy medicinal products
  441. 255Offences relating to dealings with medicinal products
  442. 255AEnforcement notices relating to Commission Regulation 2016/161: persons authorised to supply medicinal products to the public Repealed
  443. 255BException to Article 25 of Commission Regulation 2016/161: health care institutions Repealed
  444. 255COffences relating to Commission Regulation 2016/161: management of the repository system Repealed
  445. Disqualification
  446. 256Disqualification on conviction
  447. Part 12A: Sale of medicines to the public at a distance
  448. 256ZAApplication of Part
  449. 256AInterpretation
  450. 256BPerson who may sell medicinal products by information society services
  451. 256CNotification requirements for sellers of medicinal products at a distance
  452. 256DProcedure for listing persons who may supply medicinal products at a distance
  453. 256ERemoval of a person’s entry from the list
  454. 256FProvision of information to the licensing authority
  455. 256GGrant or refusal to list a person
  456. 256HConditions to be met by a person entered on the list
  457. 256IPower to suspend, vary or remove a person’s entry on the list
  458. 256JProcedure where the licensing authority proposes to suspend, vary or remove a person’s entry on the list
  459. 256KSuspension of a person’s entry on the list in cases of urgency
  460. 256LVariation of a person’s entry on the list on the application of that person
  461. 256MOffences: breach of regulations and false information
  462. 256NPenalties
  463. Part 13: Packaging and leaflets
  464. Chapter 1
  465. Requirements for packaging and package leaflets relating to medicinal products
  466. 257Packaging requirements: general
  467. 257AAPackaging requirements: variation in accordance with regulation 68(11I)
  468. 257ABTransitional arrangements
  469. 257APackaging Requirements: medicinal products required to bear safety features Repealed
  470. 257BTransitional Arrangements Repealed
  471. 257CPackaging requirements: advanced therapy medicinal products
  472. 257CAPackaging requirements: POC medicinal products
  473. 257DGuidance as to packaging and package leaflets
  474. 257ERegulation-making power as to certain forms of labelling
  475. 258Packaging requirements: specific provisions
  476. 259Packaging requirements: information for blind and partially sighted patients
  477. 260Package leaflets
  478. 261Use of pictures and symbols etc
  479. 262Labelling requirements for radionuclides
  480. 263Leaflets relating to radionuclides
  481. 264Homoeopathic medicines
  482. 265Additional requirements for traditional herbal medicinal products
  483. 266Language requirements etc
  484. 267Submission of mock-ups of packaging and leaflets to licensing authority
  485. Enforcement and offences
  486. 268Offence relating to packaging and package leaflets in Great Britain: holder of authorisation etc
  487. 268AOffence relating to packaging and package leaflets in Northern Ireland: holder of authorisation etc
  488. 269Offences relating to packaging and package leaflets in Great Britain: other persons
  489. 269AOffences relating to packaging and package leaflets in Northern Ireland: other persons
  490. 270Non-compliance with requirements of this Part
  491. 271Offences: penalties
  492. Chapter 2
  493. Requirements relating to child safety
  494. 272Interpretation
  495. 273Child resistant containers for regulated medicinal products
  496. 274Exemptions from regulation 273
  497. 275Colouring of aspirin and paracetamol products for children
  498. 276Offences
  499. Part 14: Advertising
  500. Chapter 1: General
  501. 277Interpretation
  502. 278Functions of the Ministers
  503. Chapter 2: Requirements relating to advertising
  504. General
  505. 279Products without a marketing authorisation etc
  506. 280General principles
  507. 281Duties of authorisation holders and registration holders
  508. Advertising to the public
  509. 282Application of regulations 283 to 292
  510. 283Products for the purpose of inducing abortions
  511. 284Prescription only medicines
  512. 284AMedicines with differing classification status in Great Britain and Northern Ireland
  513. 285Narcotic and psychotropic substances
  514. 286Material relating to diagnosis
  515. 287Material about effects of medicinal product
  516. 288Material about status of medicinal product
  517. 289Recommendations by scientists etc
  518. 290Advertisements directed at children
  519. 291Form and content of advertisement
  520. 291ACampaigns relating to the suspected or confirmed spread of pathogenic agents etc.
  521. 292Exception for approved vaccination campaigns
  522. Prohibition of supply to the public for promotional purposes
  523. 293Prohibition of supply to the public for promotional purposes
  524. Advertising to persons qualified to prescribe or supply etc
  525. 294General requirements
  526. 295Abbreviated advertisements
  527. 296Exception for advertisements intended as a reminder
  528. 297Written material accompanying promotions
  529. 298Free samples for persons qualified to prescribe or supply medicinal products
  530. 299Medical sales representatives
  531. 300Inducements and hospitality
  532. Homoeopathic medicinal products
  533. 301Advertisements for registered homoeopathic medicinal products
  534. Traditional herbal medicinal products
  535. 302Advertisements for traditional herbal medicinal products
  536. Offences
  537. 303Offences
  538. Chapter 3: Monitoring of Advertising
  539. Scrutiny by Ministers
  540. 304Requirement to provide copy advertisement
  541. 305Invitation to make representations about compatibility
  542. 306Decision about compatibility
  543. 307Corrective statement
  544. 308Offences
  545. Complaints to Ministers
  546. 309Complaints to Ministers: duty to consider
  547. 310Complaints to Ministers: power to refer
  548. Injunctions
  549. 311Application for injunction
  550. 312Application for injunction: accuracy of factual claim
  551. 313Grant of injunction: publication of decision and corrective statement
  552. Complaints to OFCOM
  553. 314Complaints to OFCOM
  554. General
  555. 315Public interest etc
  556. 316Civil proceedings
  557. Part 15: British Pharmacopoeia
  558. 317British Pharmacopoeia and compendia
  559. 318Lists of names
  560. 319Other documents
  561. 320Supplementary provisions
  562. 321Specified publications
  563. Part 16: Enforcement
  564. 322Validity of decisions and proceedings
  565. 323Enforcement in England, Wales and Scotland
  566. 324Enforcement in Northern Ireland
  567. 325Rights of entry
  568. 326Application for warrant
  569. 327Powers of inspection, sampling and seizure
  570. 328Regulation 327: supplementary
  571. 329Application of sampling procedure to substance or article seized under this Part
  572. 330Analysis of samples: other cases
  573. 331Findings and reports of inspections
  574. 331AGuidelines on inspections
  575. 332Restrictions on disclosure of information
  576. 333Protection for inspectors
  577. 334Supplementary provisions and offences
  578. Part 17: Miscellaneous and general
  579. Provisions relating to offences
  580. 335Contravention due to fault of another person
  581. 336Warranty as defence
  582. 337Offences in relation to warranties and certificates
  583. 338Offences by bodies corporate and partnerships
  584. Prosecutions
  585. 339Prosecutions
  586. General
  587. 340Presumptions
  588. 341Decisions under these Regulations
  589. 342Time limits for provision of information etc
  590. 343Service of documents
  591. 344Payment of expenses by Ministers
  592. 344AModifications to deal with serious shortages
  593. 344BRegulation making powers
  594. Immunity from civil liability
  595. 345Immunity from civil liability
  596. 345AObligation on licensing authority to maintain list of medicinal products to which derogations have applied
  597. Review
  598. 346Review
  599. Transitional provisions, savings, amendments, repeals and revocations
  600. 347Transitional provisions and savings
  601. 347ATransitional provision in relation to EU exit
  602. 347BTransitional provision relating to the Windsor Framework
  603. 348Amendments to existing law
  604. 349Repeals and revocations
  605. Signature
  606. Schedule 1: Further provisions for classification of medicinal products
  607. Part 1: Descriptions of certain medicinal products to be available only on prescription
  608. 1Paragraph 1
  609. 2Paragraph 2
  610. Part 2: Descriptions of certain medicinal products to be available only from a pharmacy
  611. 3Paragraph 3
  612. 4Paragraph 4
  613. 5Paragraph 5
  614. Schedule 2: Supplementary provision relating to advisory bodies and expert advisory groups
  615. Part: Terms of appointment
  616. 1Paragraph 1
  617. 2Paragraph 2
  618. 3Paragraph 3
  619. 4Paragraph 4
  620. Part: Facilities and proceedings
  621. 5Paragraph 5
  622. 6Paragraph 6
  623. 7Paragraph 7
  624. Part: Payment and expenses
  625. 8Paragraph 8
  626. 9Paragraph 9
  627. 10Paragraph 10
  628. 11Paragraph 11
  629. Part: Status
  630. 12Paragraph 12
  631. Schedule 2AModifications of Commission Directive 2003/94/EC
  632. Schedule 3: Applications for licences under Part 3
  633. Part: Manufacturer's licences
  634. 1Paragraph 1
  635. Part: Manufacturer’s licences (MM)
  636. 1AParagraph 1A
  637. Part: Manufacturer’s licence (POC)
  638. 1BParagraph 1B
  639. Part: Manufacturers' licence relating to import
  640. 2Paragraph 2
  641. Part: Wholesale dealer's licences
  642. 3Paragraph 3
  643. Part: All licences
  644. 4Paragraph 4
  645. Schedule 4: Standard provisions of licences under Part 3
  646. Part 1: Manufacturer's licence relating to manufacture and assembly
  647. 1Paragraph 1
  648. 2Paragraph 2
  649. 3Paragraph 3
  650. 4Paragraph 4
  651. 5Paragraph 5
  652. 6Paragraph 6
  653. 7Paragraph 7
  654. 8Paragraph 8
  655. 9Paragraph 9
  656. 10Paragraph 10
  657. 11Paragraph 11
  658. 12Paragraph 12
  659. 13Paragraph 13
  660. 14Paragraph 14
  661. 14AParagraph 14A
  662. 14BParagraph 14B
  663. Part 1A: Manufacturer’s licence (MM)
  664. 14CParagraph 14C
  665. 14DParagraph 14D
  666. 14EParagraph 14E
  667. 14FParagraph 14F
  668. 14GParagraph 14G
  669. 14HParagraph 14H
  670. 14IParagraph 14I
  671. 14JParagraph 14J
  672. 14KParagraph 14K
  673. Part 1B: Manufacturer’s Licence (POC)
  674. 14LParagraph 14L
  675. 14MParagraph 14M
  676. 14NParagraph 14N
  677. 14OParagraph 14O
  678. 14PParagraph 14P
  679. 14QParagraph 14Q
  680. 14RParagraph 14R
  681. 14SParagraph 14S
  682. 14TParagraph 14T
  683. 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
  684. 15Paragraph 15
  685. 15AParagraph 15A
  686. 16Paragraph 16
  687. 17Paragraph 17
  688. 18Paragraph 18
  689. 19Paragraph 19
  690. 20Paragraph 20
  691. 21Paragraph 21
  692. 22Paragraph 22
  693. 23Paragraph 23
  694. 23ZAParagraph 23ZA
  695. 23AParagraph 23A
  696. 23BParagraph 23B
  697. Part 3: Manufacturer's licence relating to exempt advanced therapy medicinal products
  698. 24Paragraph 24
  699. 25Paragraph 25
  700. 26Paragraph 26
  701. 27Paragraph 27
  702. Part 4: Wholesale dealer's licence
  703. All wholesale dealer's licences
  704. 28Paragraph 28
  705. 29Paragraph 29
  706. 30Paragraph 30
  707. 31Paragraph 31
  708. Wholesale dealer's licence relating to special medicinal products
  709. 32Paragraph 32
  710. 33Paragraph 33
  711. 33AParagraph 33A
  712. 34Paragraph 34
  713. 35Paragraph 35
  714. 36Paragraph 36
  715. 37Paragraph 37
  716. 38Paragraph 38
  717. 39Paragraph 39
  718. 40Paragraph 40
  719. 41Paragraph 41
  720. 41AParagraph 41A
  721. 42Paragraph 42
  722. Wholesale dealer's licence relating to exempt advanced therapy medicinal products
  723. 43Paragraph 43
  724. 44Paragraph 44
  725. Schedule 5: Review upon oral representations
  726. Part: Application of this Schedule
  727. 1Paragraph 1
  728. Part: Appointment of reviewers
  729. 2Paragraph 2
  730. Part: Procedure before hearing
  731. 3Paragraph 3
  732. Part: Procedure at hearing
  733. 4Paragraph 4
  734. Part: Procedure following hearing
  735. 5Paragraph 5
  736. Schedule 6: Manufacturer's and wholesale dealer's licences for exempt advanced therapy medicinal products
  737. Part 1: Manufacturer's licences
  738. 1Paragraph 1
  739. 2Paragraph 2
  740. 3Paragraph 3
  741. 4Paragraph 4
  742. 5Paragraph 5
  743. 6Paragraph 6
  744. 7Paragraph 7
  745. 8Paragraph 8
  746. 9Paragraph 9
  747. 10Paragraph 10
  748. 11Paragraph 11
  749. 12Paragraph 12
  750. Part 2: Wholesale dealer's licences
  751. 13Paragraph 13
  752. 14Paragraph 14
  753. 15Paragraph 15
  754. 16Paragraph 16
  755. 17Paragraph 17
  756. 18Paragraph 18
  757. 19Paragraph 19
  758. 20Paragraph 20
  759. Schedule 7: Qualified persons
  760. Part 1: Qualification requirements for qualified person
  761. 1Paragraph 1
  762. 2Paragraph 2
  763. 3Paragraph 3
  764. 4Paragraph 4
  765. 5Paragraph 5
  766. 6Paragraph 6
  767. 7Paragraph 7
  768. 8Paragraph 8
  769. Part 2: Qualified persons with long experience
  770. 9Paragraph 9
  771. 10Paragraph 10
  772. 11Paragraph 11
  773. Part 3: Obligations of qualified person
  774. 12Paragraph 12
  775. 12AParagraph 12A
  776. 12BParagraph 12B
  777. 13Paragraph 13
  778. 14Paragraph 14
  779. 15Paragraph 15
  780. Schedule 7A: Information to be provided for registration as an importer, manufacturer or distributor of active substances
  781. 1Paragraph 1
  782. 2Paragraph 2
  783. 3Paragraph 3
  784. 4Paragraph 4
  785. 5Paragraph 5
  786. 6Paragraph 6
  787. 7Paragraph 7
  788. 8Paragraph 8
  789. 9Paragraph 9
  790. 10Paragraph 10
  791. 11Paragraph 11
  792. 12Paragraph 12
  793. 13Paragraph 13
  794. 14Paragraph 14
  795. 15Paragraph 15
  796. 16Paragraph 16
  797. 17Paragraph 17
  798. 18Paragraph 18
  799. 19Paragraph 19
  800. 20Paragraph 20
  801. 21Paragraph 21
  802. 22Paragraph 22
  803. 23Paragraph 23
  804. 24Paragraph 24
  805. Schedule 8: Material to accompany an application for a UK marketing authorisation
  806. Part 1: General requirements
  807. 1Paragraph 1
  808. 2Paragraph 2
  809. 3Paragraph 3
  810. 4Paragraph 4
  811. 5Paragraph 5
  812. 6Paragraph 6
  813. 7Paragraph 7
  814. 8Paragraph 8
  815. 9Paragraph 9
  816. 9AParagraph 9A
  817. 10Paragraph 10
  818. 11Paragraph 11
  819. 12Paragraph 12
  820. 13Paragraph 13
  821. 14Paragraph 14
  822. 15Paragraph 15
  823. 16Paragraph 16
  824. 17Paragraph 17
  825. 18Paragraph 18
  826. 19Paragraph 19
  827. 20Paragraph 20
  828. 21Paragraph 21
  829. 22Paragraph 22
  830. 2Summary of the product characteristics
  831. 23Paragraph 23
  832. 24Paragraph 24
  833. 25Paragraph 25
  834. 25AParagraph 25A
  835. 26Paragraph 26
  836. 27Paragraph 27
  837. 28Paragraph 28
  838. 29Paragraph 29
  839. 30Paragraph 30
  840. 31Paragraph 31
  841. 32Paragraph 32
  842. 33Paragraph 33
  843. 34Paragraph 34
  844. 35Paragraph 35
  845. 36Paragraph 36
  846. Schedule 8A: Material to accompany an application for a parallel import licence
  847. 1Paragraph 1
  848. 2Paragraph 2
  849. 3Paragraph 3
  850. 4Paragraph 4
  851. 5Paragraph 5
  852. 6Paragraph 6
  853. 7Paragraph 7
  854. 8Paragraph 8
  855. 9Paragraph 9
  856. Schedule 8BModifications of Annex I to the 2001 Directive
  857. Schedule 8C: Material to accompany an application for a UK marketing authorisation under the unfettered access route
  858. 1Paragraph 1
  859. 2Paragraph 2
  860. 3Paragraph 3
  861. Schedule 9: Undertakings by non- United Kingdom manufacturers
  862. 1Paragraph 1
  863. 2Paragraph 2
  864. 3Paragraph 3
  865. 4Paragraph 4
  866. 5Paragraph 5
  867. 6Paragraph 6
  868. 7Paragraph 7
  869. 8Paragraph 8
  870. 9Paragraph 9
  871. 10Paragraph 10
  872. 11Paragraph 11
  873. 12Paragraph 12
  874. Schedule 9A: Meaning of terms used in the orphan criteria and in regulation 58D
  875. 1Prevalence of a condition in the United Kingdom
  876. 2Potential for return on investment
  877. 3Existence of other methods of diagnosis, prevention or treatment
  878. 4Increased safety or effectiveness and clinical superiority
  879. 5Paragraph 5
  880. 6Paragraph 6
  881. 7Paragraph 7
  882. 8Paragraph 8
  883. Schedule 10: National homoeopathic products
  884. Part: Meaning of “national homoeopathic product”
  885. 1Paragraph 1
  886. Part: General requirements for application
  887. 2Paragraph 2
  888. Part: Requirement to submit safety data
  889. 3Paragraph 3
  890. Part: Exceptions to requirement to submit safety data
  891. 4Paragraph 4
  892. Part: Requirement to submit efficacy data
  893. 5Paragraph 5
  894. Schedule 10A: Variations to a UK marketing authorisation
  895. 1Interpretation
  896. 2Classification of variations
  897. 3Licensing authority recommendation on unclassified variations
  898. 4Variations leading to the revision of product information
  899. 5Grouping of variations
  900. 6Notification procedure for minor variations of type IA
  901. 7Notification procedure for minor variations of type IB
  902. 8Prior approval procedure for major variations of type II
  903. 9Elements to be submitted
  904. 10Measures to close the procedures specified in paragraphs 6 to 8
  905. 11Extensions of marketing authorisations
  906. 12Human influenza vaccines
  907. 13Pandemic situation with respect to human influenza
  908. 14Urgent safety restrictions
  909. 15Amendments to the decision granting the marketing authorisation
  910. 16Implementation of variations
  911. 17Continuous monitoring
  912. Schedule 11: Advice and representations
  913. Part 1: General procedures
  914. Application of this Part
  915. 1Paragraph 1
  916. Requirement to consult the appropriate committee
  917. 2Paragraph 2
  918. Exceptions to requirement to consult
  919. 3Paragraph 3
  920. 4Paragraph 4
  921. Provisional opinion against authorisation
  922. 5Paragraph 5
  923. Opportunity to make representations
  924. 6Paragraph 6
  925. Written representations
  926. 7Paragraph 7
  927. Oral representations
  928. 8Paragraph 8
  929. Other decisions of the appropriate committee
  930. 9Paragraph 9
  931. Decision of licensing authority
  932. 10Paragraph 10
  933. Right to review after paragraph 10 notification
  934. 11Paragraph 11
  935. Licensing authority decisions in other cases
  936. 12Paragraph 12
  937. Right to review or representations after paragraph 12 notification
  938. 13Paragraph 13
  939. Part 1A: Paediatric Decisions
  940. 13AApplication of this Part
  941. 13BOpportunity to make representations
  942. 13CWritten representations
  943. 13DOral representations
  944. 13EOther decisions of the appropriate committee
  945. 13FDecision of licensing authority
  946. 13GRight to review after paragraph 13F notification
  947. Part 2: Type II variation applications, complex variation applications and new excipient variation applications
  948. Application of this Part
  949. 14Paragraph 14
  950. 15Paragraph 15
  951. 16Paragraph 16
  952. 17Paragraph 17
  953. Opportunity to make representations
  954. 18Paragraph 18
  955. Written representations
  956. 19Paragraph 19
  957. Oral representations
  958. 20Paragraph 20
  959. Other decisions of the appropriate committee
  960. 21Paragraph 21
  961. Decision of licensing authority following report
  962. 22Paragraph 22
  963. Right to review after paragraph 22 notification
  964. 23Paragraph 23
  965. Part 3: Referral to the appropriate committee for traditional herbal registrations
  966. Application of this Part
  967. 24Paragraph 24
  968. Opportunity to make representations
  969. 25Paragraph 25
  970. Written representations
  971. 26Paragraph 26
  972. Oral representations
  973. 27Paragraph 27
  974. Other decisions of the appropriate committee
  975. 28Paragraph 28
  976. Decision of licensing authority following report
  977. 29Paragraph 29
  978. Right to review after paragraph 29 notification
  979. 30Paragraph 30
  980. Part 4: Exceptions to Schedule
  981. 31Paragraph 31 Repealed
  982. 32Paragraph 32
  983. 33Paragraph 33
  984. 34Paragraph 34 Repealed
  985. 35Paragraph 35 Repealed
  986. 36Paragraph 36
  987. 37Paragraph 37 Repealed
  988. 38Paragraph 38 Repealed
  989. 39Paragraph 39
  990. Schedule 12: Material to accompany an application for a traditional herbal registration
  991. Part 1: General requirements
  992. 1Paragraph 1
  993. 2Paragraph 2
  994. 3Paragraph 3
  995. 4Paragraph 4
  996. 5Paragraph 5
  997. 6Paragraph 6
  998. 7Paragraph 7
  999. 8Paragraph 8
  1000. 9Paragraph 9
  1001. 10Paragraph 10
  1002. 11Paragraph 11
  1003. 12Paragraph 12
  1004. 13Paragraph 13
  1005. 14Paragraph 14
  1006. 15Paragraph 15
  1007. 16Paragraph 16
  1008. 17Paragraph 17
  1009. 18Paragraph 18
  1010. 19Paragraph 19
  1011. 20Paragraph 20
  1012. 2Summary of the product characteristics
  1013. 21Paragraph 21
  1014. 22Paragraph 22
  1015. 23Paragraph 23
  1016. 24Paragraph 24
  1017. 25Paragraph 25
  1018. 26Paragraph 26
  1019. 27Paragraph 27
  1020. 28Paragraph 28
  1021. 29Paragraph 29
  1022. 30Paragraph 30
  1023. Schedule 12A: Further provision as to the performance of pharmacovigilance activities
  1024. Part 1: Pharmacovigilance system master file
  1025. 1Structure of the pharmacovigilance system master file
  1026. 2Content of the pharmacovigilance system master file
  1027. 3Content of the Annex to the pharmacovigilance system master file
  1028. 4Maintenance of the pharmacovigilance system master file
  1029. 5Form of the documents contained in the pharmacovigilance system master file
  1030. 6Subcontracting
  1031. 7Availability and location of the pharmacovigilance system master file
  1032. Part 2: Minimum requirements for the quality systems for the performance of pharmacovigilance activities by the licensing authority and holders
  1033. 8Quality system
  1034. 9Performance indicators
  1035. Part 3: Minimum requirements for the quality systems for the performance of pharmacovigilance activities by holders
  1036. 10Management of human resources
  1037. 11Compliance management
  1038. 12Record management and data retention
  1039. 13Audit
  1040. Part 4: Minimum requirements for the quality systems for the performance of pharmacovigilance activities by the licensing authority
  1041. 14Management of human resources
  1042. 15Compliance management
  1043. 16Record management and data retention
  1044. 17Audit
  1045. Part 5: Use of terminology, formats and standards
  1046. 18Use of internationally agreed terminology, formats and standards
  1047. Part 6: Transmission of reports of suspected adverse reactions
  1048. 19Individual case safety reports
  1049. 20Content of the individual case safety report
  1050. 21Format of electronic transmission of suspected adverse reactions
  1051. Part 7: Risk management plans
  1052. 22Content of the risk management plan
  1053. 23Summary of the risk management plan
  1054. 24Updates of the risk management plan
  1055. 25Format of the risk management plan
  1056. Part 8: Periodic safety update reports
  1057. 26Content of periodic safety update reports
  1058. 27Format of periodic safety update reports
  1059. Part 9: Post-authorisation safety studies
  1060. 28Scope and interpretation
  1061. 29Obligations as to post-authorisation safety studies
  1062. 30Format of the study protocol
  1063. 31Format of the abstract of the final study report
  1064. 32Format of the final study report
  1065. Schedule 13: Prescription only medicines for which community practitioner nurse prescribers are appropriate practitioners
  1066. Paragraph
  1067. Schedule 14: Prescription etc by supplementary prescribers: particulars of clinical management plan
  1068. Paragraph
  1069. Schedule 15: Requirements for specific products subject to general sale
  1070. 1Paragraph 1
  1071. 2Paragraph 2
  1072. Schedule 16: Patient group directions and vaccine group directions
  1073. Part 1: Particulars to be included in a patient group direction and a vaccine group direction
  1074. 1Paragraph 1
  1075. 2Paragraph 2
  1076. 3Paragraph 3
  1077. 4Paragraph 4
  1078. 5Paragraph 5
  1079. 6Paragraph 6
  1080. 7Paragraph 7
  1081. 8Paragraph 8
  1082. 9Paragraph 9
  1083. 10Paragraph 10
  1084. 11Paragraph 11
  1085. 12Paragraph 12
  1086. 13Paragraph 13
  1087. 14Paragraph 14
  1088. 15Paragraph 15
  1089. 16Paragraph 16
  1090. 17Paragraph 17
  1091. 2Persons on whose behalf a patient group Direction must be signed
  1092. 3Persons by whom or on whose behalf a patient group direction used as described in regulation 234 must be signed
  1093. Part 4: Classes of individuals by whom supplies may be made
  1094. Paragraph
  1095. Schedule 17: Exemption for sale, supply or administration by certain persons
  1096. 1Exemption from restrictions on sale and supply of prescription only medicines
  1097. 2Exemption from the restriction on supply of prescription only medicines
  1098. 3Exemptions from the restriction on administration of prescription only medicines
  1099. 4Exemptions from the restrictions in regulations 220 and 221 for certain persons who sell, supply, or offer for sale or supply certain medicinal products
  1100. 5Exemptions from the restrictions in regulations 220 and 221 for certain persons who supply certain medicinal products
  1101. Schedule 18: Substances that may not be sold or supplied by a pharmacist without a prescription in reliance on regulation 225
  1102. Paragraph
  1103. Schedule 19: Medicinal products for parenteral administration in an emergency
  1104. Paragraph
  1105. Schedule 20: Herbal medicinal products specified for the purposes of regulation 241
  1106. 1Part 1
  1107. 2Part 2
  1108. Schedule 21: Medicinal products at high dilutions
  1109. Part 1: Dilutions of unit preparations diluted to at least one part in a thousand (3x)
  1110. Paragraph
  1111. Part 2: Dilutions of unit preparations diluted to at least one part in a million (6x)
  1112. Paragraph
  1113. Part 3: Dilutions of unit preparations diluted to at least one part in ten (1x)
  1114. Paragraph
  1115. Part 4: Dilutions of unit preparations diluted to at least one part in ten (1x) for external use
  1116. Paragraph
  1117. Schedule 22Classes of person for the purposes of regulation 249
  1118. Schedule 23: Particulars in pharmacy records
  1119. 1Paragraph 1
  1120. 2Paragraph 2
  1121. 3Paragraph 3
  1122. 4Paragraph 4
  1123. 5Paragraph 5
  1124. 6Paragraph 6
  1125. Schedule 24: Packaging information requirements
  1126. Part 1: Outer and immediate packaging
  1127. 1Paragraph 1
  1128. 2Paragraph 2
  1129. 3Paragraph 3
  1130. 4Paragraph 4
  1131. 5Paragraph 5
  1132. 6Paragraph 6
  1133. 7Paragraph 7
  1134. 8Paragraph 8
  1135. 9Paragraph 9
  1136. 10Paragraph 10
  1137. 11Paragraph 11
  1138. 12Paragraph 12
  1139. 13Paragraph 13
  1140. 14Paragraph 14
  1141. 15Paragraph 15
  1142. 16Paragraph 16
  1143. 17Paragraph 17
  1144. 18Paragraph 18
  1145. 18AParagraph 18A Repealed
  1146. 18BParagraph 18B
  1147. Part 2: Immediate packaging: blister packs
  1148. 19Paragraph 19
  1149. 20Paragraph 20
  1150. 21Paragraph 21
  1151. 22Paragraph 22
  1152. 23Paragraph 23
  1153. 24Paragraph 24
  1154. 25Paragraph 25
  1155. Part 3: Immediate packaging: small packages
  1156. 26Paragraph 26
  1157. 27Paragraph 27
  1158. 28Paragraph 28
  1159. 29Paragraph 29
  1160. 30Paragraph 30
  1161. 31Paragraph 31
  1162. 32Paragraph 32
  1163. 33Paragraph 33
  1164. Part 4: Outer and immediate packaging: advanced therapy medicinal products ...
  1165. 34Paragraph 34
  1166. 35Paragraph 35
  1167. 36Paragraph 36
  1168. 37Paragraph 37
  1169. 38Paragraph 38
  1170. 39Paragraph 39
  1171. 40Paragraph 40
  1172. 41Paragraph 41
  1173. 42Paragraph 42
  1174. 43Paragraph 43
  1175. 44Paragraph 44
  1176. 45Paragraph 45
  1177. 46Paragraph 46
  1178. 47Paragraph 47
  1179. 48Paragraph 48
  1180. 49Paragraph 49
  1181. 50Paragraph 50
  1182. Part 5: Immediate packaging: blister packs and small packaging (advanced therapy medicinal products ...)
  1183. 51Paragraph 51
  1184. 52Paragraph 52
  1185. 53Paragraph 53
  1186. Part 6: Outer and Immediate Packaging: POC Medicinal Products for sale or supply in Great Britain only
  1187. 54Paragraph 54
  1188. 55Paragraph 55
  1189. 56Paragraph 56
  1190. 57Paragraph 57
  1191. 58Paragraph 58
  1192. 59Paragraph 59
  1193. 60Paragraph 60
  1194. 61Paragraph 61
  1195. 62Paragraph 62
  1196. 63Paragraph 63
  1197. 64Paragraph 64
  1198. 65Paragraph 65
  1199. 66Paragraph 66
  1200. 67Paragraph 67
  1201. 68Paragraph 68
  1202. 69Paragraph 69
  1203. 70Paragraph 70
  1204. Part 7: Immediate Packaging: Blister Packs and Small Packaging (POC Medicinal Products for sale or supply in Great Britain only)
  1205. 71Paragraph 71
  1206. 72Paragraph 72
  1207. 73Paragraph 73
  1208. 74Paragraph 74
  1209. 75Paragraph 75
  1210. 76Paragraph 76
  1211. 77Paragraph 77
  1212. 78Paragraph 78
  1213. 79Paragraph 79
  1214. 80Paragraph 80
  1215. Schedule 25: Packaging requirements: specific provisions
  1216. Part 1: Medicines on prescription
  1217. 1Paragraph 1
  1218. 2Paragraph 2
  1219. 3Paragraph 3
  1220. 4Paragraph 4
  1221. 5Paragraph 5
  1222. 6Paragraph 6
  1223. 6AParagraph 6A
  1224. Part 2: Transport, delivery and storage
  1225. 7Paragraph 7
  1226. 8Paragraph 8
  1227. 9Paragraph 9
  1228. Part 3: Pharmacy and prescription only medicines
  1229. 10Paragraph 10
  1230. 11Paragraph 11
  1231. 12Paragraph 12
  1232. 13Paragraph 13
  1233. Part 4: Medicines containing paracetamol
  1234. 14Paragraph 14
  1235. 15Paragraph 15
  1236. 16Paragraph 16
  1237. 17Paragraph 17
  1238. 18Paragraph 18
  1239. Schedule 26: Packaging requirements: special provisions
  1240. Part 1: Supply by doctors, dentists, nurses, midwives and pharmacists
  1241. 1Paragraph 1
  1242. 2Paragraph 2
  1243. 3Paragraph 3
  1244. 4Paragraph 4
  1245. 4AParagraph 4A
  1246. Part 2: Pharmacy exceptions
  1247. 5Paragraph 5
  1248. 6Paragraph 6
  1249. 7Paragraph 7
  1250. 8Paragraph 8
  1251. 9Paragraph 9
  1252. 10Paragraph 10
  1253. 10AParagraph 10A
  1254. 11Paragraph 11
  1255. Schedule 27: Package leaflets
  1256. Part 1: General requirements
  1257. 1Paragraph 1
  1258. 2Paragraph 2
  1259. 3Paragraph 3
  1260. 4Paragraph 4
  1261. 5Paragraph 5
  1262. 6Paragraph 6
  1263. 7Paragraph 7
  1264. 8Paragraph 8
  1265. 9Paragraph 9
  1266. 10Paragraph 10
  1267. 11Paragraph 11
  1268. 12Paragraph 12
  1269. 13Paragraph 13
  1270. 14Paragraph 14
  1271. 15Paragraph 15
  1272. Part 2: Paracetamol
  1273. 16Paragraph 16
  1274. 17Paragraph 17
  1275. Part 3: Advanced therapy medicinal products ...
  1276. 18Paragraph 18
  1277. 19Paragraph 19
  1278. 20Paragraph 20
  1279. 21Paragraph 21
  1280. 22Paragraph 22
  1281. 23Paragraph 23
  1282. 24Paragraph 24
  1283. 25Paragraph 25
  1284. 26Paragraph 26
  1285. 27Paragraph 27
  1286. 28Paragraph 28
  1287. 29Paragraph 29
  1288. 30Paragraph 30
  1289. Schedule 28: Labelling requirements for registrable homoeopathic medicinal products
  1290. Part 1: Outer and immediate packaging
  1291. 1Paragraph 1
  1292. 2Paragraph 2
  1293. 3Paragraph 3
  1294. 4Paragraph 4
  1295. 5Paragraph 5
  1296. 6Paragraph 6
  1297. 7Paragraph 7
  1298. 8Paragraph 8
  1299. 9Paragraph 9
  1300. 10Paragraph 10
  1301. 11Paragraph 11
  1302. 12Paragraph 12
  1303. Part 2: Blister packs etc contained in outer packaging
  1304. 13Paragraph 13
  1305. 14Paragraph 14
  1306. 15Paragraph 15
  1307. 16Paragraph 16
  1308. 17Paragraph 17
  1309. Part 3: Small immediate packaging
  1310. 18Paragraph 18
  1311. 19Paragraph 19
  1312. 20Paragraph 20
  1313. 21Paragraph 21
  1314. 22Paragraph 22
  1315. 23Paragraph 23
  1316. 24Paragraph 24
  1317. Schedule 29: Labelling of traditional herbal medicinal products
  1318. Part 1: Traditional herbal medicinal products: general
  1319. 1Paragraph 1
  1320. 2Paragraph 2
  1321. Part 2: Traditional herbal medicinal products not subject to general sale
  1322. 3Paragraph 3
  1323. 4Paragraph 4
  1324. Schedule 30: Particulars for advertisements to persons qualified to prescribe or supply
  1325. 1Paragraph 1
  1326. 2Paragraph 2
  1327. 2AParagraph 2A
  1328. 3Paragraph 3
  1329. 4Paragraph 4
  1330. 5Paragraph 5
  1331. 6Paragraph 6
  1332. 7Paragraph 7
  1333. 8Paragraph 8
  1334. 9Paragraph 9
  1335. Schedule 31: Sampling
  1336. Part: Introductory
  1337. 1Paragraph 1
  1338. Part: Division of sample
  1339. 2Paragraph 2
  1340. 3Paragraph 3
  1341. 4Paragraph 4
  1342. 5Paragraph 5
  1343. 6Paragraph 6
  1344. 7Paragraph 7
  1345. 8Paragraph 8
  1346. 9Paragraph 9
  1347. 10Paragraph 10
  1348. 11Paragraph 11
  1349. 12Paragraph 12
  1350. 13Paragraph 13
  1351. Part: Notice to person named on container
  1352. 14Paragraph 14
  1353. Part: Analysis or other examination
  1354. 15Paragraph 15
  1355. 16Paragraph 16
  1356. 17Paragraph 17
  1357. 18Paragraph 18
  1358. 19Paragraph 19
  1359. 20Paragraph 20
  1360. Part: Provisions as to evidence
  1361. 21Paragraph 21
  1362. 22Paragraph 22
  1363. 23Paragraph 23
  1364. Part: Analysis under direction of court
  1365. 24Paragraph 24
  1366. 25Paragraph 25
  1367. Part: Proof by written statement
  1368. 26Paragraph 26
  1369. Part: Payment for sample taken under compulsory powers
  1370. 27Paragraph 27
  1371. Schedule 32: Transitional provisions and savings
  1372. Part: Continuity of the law
  1373. 1Paragraph 1
  1374. Part: Product licences
  1375. 2Paragraph 2
  1376. Part: Product licences of right
  1377. 3Paragraph 3
  1378. Part: Classification of UK marketing authorisation and certificate of registration
  1379. 4Paragraph 4
  1380. Part: Advanced therapy medicinal products
  1381. 5Paragraph 5
  1382. Part: Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010 (S.I. 2010/1882)
  1383. 6Paragraph 6
  1384. Part: Section 60 of the Medicines Act 1968 etc
  1385. 7Paragraph 7
  1386. Schedule 33: Transitional arrangements: pharmacovigilance
  1387. 1Pharmacovigilance system master file Repealed
  1388. 2Paragraph 2 Repealed
  1389. 3Post-authorisation safety studies
  1390. 4Paragraph 4
  1391. 5Reporting obligations Repealed
  1392. 6Paragraph 6 Repealed
  1393. 7Paragraph 7 Repealed
  1394. 8Paragraph 8 Repealed
  1395. 9Periodic safety update reports Repealed
  1396. 10Paragraph 10 Repealed
  1397. Schedule 33A: Transitional provision in relation to EU Exit
  1398. Part 1: Interpretation
  1399. 1Paragraph 1
  1400. Part 2: Manufacturing, wholesale dealing and brokering
  1401. 2Wholesale dealer's licence used to distribute a medicinal product imported from an EEA State before IP completion day
  1402. 3Approved country for import list on IP completion day (regulation 18A)
  1403. 4Qualified persons and approved country for batch testing list on IP completion day (Schedule 7)
  1404. 5List of countries with equivalent regulatory standards as to the manufacturing of active substances on IP completion day (regulation 45O(6) to (9))
  1405. Part 3: Transitional provision in respect of conversion of EU marketing authorisations in force immediately before IP completion day
  1406. 6Conversion of EU marketing authorisations in force before IP completion day
  1407. 7Classification of converted EU marketing authorisations
  1408. 8Obligations of licensing authority in connection with converted EU marketing authorisations
  1409. 9Obligations of holders of converted EU marketing authorisations
  1410. 10Powers of licensing authority in connection with provision of information
  1411. 11Variations of converted EU marketing authorisations notified or applied for before IP completion day
  1412. 12Variations of converted EU marketing authorisations submitted to EMA after IP completion day but before the data submission date
  1413. 13Variations of converted EU marketing authorisations sought in advance of the data submission date
  1414. 14Applications for renewals of converted EU marketing authorisations made before IP completion day
  1415. 15Applications for renewals of conditional marketing authorisations made before IP completion day
  1416. 16Applications for renewals of converted EU marketing authorisations made after IP completion day
  1417. 17Applications for renewals of conditional marketing authorisations made after IP completion day
  1418. 18Renewals of converted EU marketing authorisations sought in advance of the data submission date
  1419. 19Article 61(3) notifications made before IP completion day in relation to converted EU marketing authorisations
  1420. 20Article 61(3) notifications made in relation to converted EU marketing authorisations after IP completion day but before the data submission date
  1421. 21Article 61(3) notifications sought in advance of the data submission date
  1422. 22Place of establishment for converted EU marketing authorisation holder established in EEA state before IP completion day
  1423. 23Temporary exemption as to packaging requirements for converted EU marketing authorisations
  1424. 24Referrals made under Article 20 of Regulation (EC) No 726/2004 that have not concluded or been implemented before IP completion day
  1425. 25Enforcement
  1426. Part 4: Transitional provision in respect of UK marketing authorisations, parallel import licences and parallel distribution notices
  1427. 26ZAStatus of certain UK marketing authorisations granted before IP completion day
  1428. 26Place of establishment for UK marketing authorisation holder or parallel import licence holder established in an EEA State before IP completion day
  1429. 27Temporary exemption as to packaging requirements: change of place of establishment
  1430. 27AStatus of parallel import licences granted before IP completion day
  1431. 28Conversion of parallel distribution notices in to parallel import licences
  1432. 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)
  1433. 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
  1434. 30Existing data and marketing exclusivity and global marketing authorisations
  1435. 31Applications for EU marketing authorisations made before IP completion day
  1436. 32Place of establishment for UK marketing authorisation holder established in EEA state before IP completion day (pre-exit EU marketing authorisation applications)
  1437. 33Packaging in relation to UK marketing authorisations granted in response to application for EU marketing authorisation made before IP completion day
  1438. 34Applications made for a UK marketing authorisation before IP completion day to which Chapter 4 of Title III of the 2001 Directive applied
  1439. 35Transitional provision in respect of Plasma Master Files
  1440. 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
  1441. 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
  1442. Part 5: Transitional provision in relation to variations of marketing authorisations other than converted EU marketing authorisations
  1443. 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)
  1444. 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)
  1445. 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)
  1446. Part 6: Transitional provision in relation to the Paediatric Regulation
  1447. 41Transitional provision in relation to applications made to EMA before IP completion day under the Paediatric Regulation
  1448. 41ATransitional provision in relation to global marketing authorisations under the 2001 Directive
  1449. Part 8: Transitional provision in respect of homoeopathic medicinal products
  1450. 43List of countries for the purposes of the definition of “homoeopathic medicinal product” on IP completion day
  1451. 44Place of establishment for holders of certificates of registration established in EEA before IP completion day
  1452. 45Temporary exemption as to packaging requirements: change of place of establishment
  1453. 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
  1454. 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
  1455. 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
  1456. Part 9: Transitional provision in respect of traditional herbal registrations
  1457. 49Place of establishment for holders of traditional herbal registrations established in EEA before IP completion day
  1458. 50Temporary exemption as to packaging requirements: change of place of establishment
  1459. 51List of approved countries for traditional use of a herbal medicinal product on IP completion day
  1460. 52Applications made for a traditional herbal registration before IP completion day to which Chapter 4 of Title III of the 2001 Directive applied
  1461. 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
  1462. 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
  1463. 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
  1464. Part 10: Transitional provision in respect of pharmacovigilance
  1465. 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
  1466. 59Matters on-going at IP completion day in respect of periodic safety update reports
  1467. 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)
  1468. 61Matters on-going at IP completion day in respect of the follow up of final study reports
  1469. Part 11: Transitional provision in respect of Part 12
  1470. 62Approved country health professional list on IP completion day (regulation 214(6A))
  1471. Part 12: General provision in relation to transitional provisions
  1472. 63Licensing authority power to require information
  1473. Schedule 33B: Transitional Provision in relation to the Windsor Framework
  1474. 1Existing marketing authorisations
  1475. 2Existing applications for marketing authorisation
  1476. 3Post-authorisation processes
  1477. Schedule 34: Amendments to existing law
  1478. Part 1: The Medicines Acts 1968 and 1971
  1479. 1Paragraph 1
  1480. 2Paragraph 2
  1481. 3Paragraph 3
  1482. 4Paragraph 4
  1483. 5Paragraph 5
  1484. 6Paragraph 6
  1485. 7Paragraph 7
  1486. 8Paragraph 8
  1487. 9Paragraph 9
  1488. 10Paragraph 10
  1489. 11Paragraph 11
  1490. 12Paragraph 12
  1491. 13Paragraph 13
  1492. 14Paragraph 14
  1493. 15Paragraph 15
  1494. 16Paragraph 16
  1495. 17Paragraph 17
  1496. 18Paragraph 18
  1497. 19Paragraph 19
  1498. 20Paragraph 20
  1499. 21Paragraph 21
  1500. 22Paragraph 22
  1501. 23Paragraph 23
  1502. 24Paragraph 24
  1503. 25Paragraph 25
  1504. 26Paragraph 26
  1505. 27Paragraph 27
  1506. 28Paragraph 28
  1507. 29Paragraph 29
  1508. 30Paragraph 30
  1509. 31Paragraph 31
  1510. 32Paragraph 32
  1511. 33Paragraph 33
  1512. 34Paragraph 34
  1513. 35Paragraph 35
  1514. Medicines Act 1971
  1515. 36Paragraph 36
  1516. Part 2: Other primary legislation
  1517. Trade Descriptions Act 1968
  1518. 37Paragraph 37
  1519. House of Commons Disqualification Act 1975
  1520. 38Paragraph 38
  1521. Northern Ireland Assembly Disqualification Act 1975
  1522. 39Paragraph 39
  1523. Consumer Protection Act 1987
  1524. 40Paragraph 40
  1525. Environmental Protection Act 1990
  1526. 41Paragraph 41
  1527. Value Added Tax Act 1994
  1528. 42Paragraph 42
  1529. Health Act 1999
  1530. 43Paragraph 43
  1531. Communications Act 2003
  1532. 44Paragraph 44
  1533. Christmas Day and New Year's Day Trading (Scotland) Act 2007
  1534. 45Paragraph 45
  1535. Part 3: Northern Ireland Orders in Council
  1536. Health and Personal Social Services (Northern Ireland) Order 1972
  1537. 46Paragraph 46
  1538. Pharmacy (Northern Ireland) Order 1976
  1539. 47Paragraph 47
  1540. Poisons (Northern Ireland) Order 1976
  1541. 48Paragraph 48
  1542. Diseases of Animals (Northern Ireland) Order 1981
  1543. 49Paragraph 49
  1544. Waste and Contaminated Land (Northern Ireland) Order 1997
  1545. 50Paragraph 50
  1546. Shops (Sunday Trading &c.) (Northern Ireland) Order 1997
  1547. 51Paragraph 51
  1548. Part 4: The Medicines for Human Use (Clinical Trials) Regulations 2004
  1549. 52Paragraph 52
  1550. 53Paragraph 53
  1551. 54Paragraph 54
  1552. 55Paragraph 55
  1553. 56Paragraph 56
  1554. 57Paragraph 57
  1555. 58Paragraph 58
  1556. 59Paragraph 59
  1557. 60Paragraph 60
  1558. 61Paragraph 61
  1559. 62Paragraph 62
  1560. 63Paragraph 63
  1561. 64Paragraph 64
  1562. Part 5: Other United Kingdom, Scotland and Wales Secondary legislation
  1563. Medicines (Administration of Radioactive Substances) Regulations 1978
  1564. 65Paragraph 65
  1565. Importation of Animal Products and Poultry Products Order 1980
  1566. 66Paragraph 66
  1567. Medicines Act (Hearings by Persons Appointed) (Scotland) Rules 1986
  1568. 67Paragraph 67
  1569. Medicines Act (Hearings by Persons Appointed) Rules 1986
  1570. 68Paragraph 68
  1571. Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Order 1989
  1572. 69Paragraph 69
  1573. Medical Devices (Consultation Requirements) (Fees) Regulations 1995
  1574. 70Paragraph 70
  1575. Prescription Only Medicines (Human Use) Order 1997
  1576. 71Paragraph 71
  1577. General Optical Council (Rules relating to Injury or Disease of the Eye) Order of Council 1999
  1578. 72Paragraph 72
  1579. National Health Service (Charges for Drugs and Appliances) Regulations 2000
  1580. 73Paragraph 73
  1581. Biocidal Products Regulations 2001
  1582. 74Paragraph 74
  1583. Medicines (Aristolochia and Mu Tong etc) (Prohibition Order) 2001
  1584. 75Paragraph 75
  1585. Misuse of Drugs Regulations 2001
  1586. 76Paragraph 76
  1587. Medicines for Human Use (Kava-kava) (Prohibition Order) 2002
  1588. 77Paragraph 77
  1589. Medicines and Healthcare Products Regulatory Agency Trading Fund Order 2003
  1590. 78Paragraph 78 Repealed
  1591. Enterprise Act 2002 (Part 8 Community Infringements Specified UK Laws) Order 2003
  1592. 79Paragraph 79
  1593. Enterprise Act 2002 (Part 8 Notice to OFT of Intended Prosecution Specified Enactments, Revocation and Transitional Provision) Order 2003
  1594. 80Paragraph 80
  1595. Health Professions (Parts of and Entries in the Register) Order of Council 2003
  1596. 81Paragraph 81
  1597. Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003
  1598. 82Paragraph 82
  1599. National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004
  1600. 83Paragraph 83
  1601. National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2004
  1602. 84Paragraph 84
  1603. National Health Service (General Medical Services Contracts) Regulations 2004
  1604. 85Paragraph 85 Repealed
  1605. National Health Service (General Medical Services Contracts) (Wales) Regulations 2004
  1606. 86Paragraph 86
  1607. National Health Service (Personal Medical Services Agreements) Regulations 2004
  1608. 87Paragraph 87 Repealed
  1609. National Health Service (General Medical Services Contracts) (Prescription of Drugs Etc.) (Wales) Regulations 2004
  1610. 88Paragraph 88
  1611. Contracting Out (Functions relating to Broadcast Advertising) and Specification of Relevant Functions Order 2004
  1612. 89Paragraph 89
  1613. General Optical Council (Registration Rules) Order of Council 2005
  1614. 90Paragraph 90
  1615. National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) Regulations 2007
  1616. 91Paragraph 91
  1617. Human Tissue (Quality and Safety for Human Application) Regulations 2007
  1618. 92Paragraph 92
  1619. Legislative and Regulatory Reform (Regulatory Functions) Order 2007
  1620. 93Paragraph 93
  1621. Medicines for Human Use (Prohibition) (Senecio and Miscellaneous Amendments) Order 2008
  1622. 94Paragraph 94
  1623. Specified Animal Pathogens Order 2008
  1624. 95Paragraph 95
  1625. Specified Animal Pathogens (Wales) Order 2008
  1626. 96Paragraph 96
  1627. Health Service Branded Medicines (Control of Prices and Supply of Information) (No 2) Regulations 2008
  1628. 97Paragraph 97
  1629. Specified Animal Pathogens (Scotland) Order 2009
  1630. 98Paragraph 98
  1631. National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009
  1632. 99Paragraph 99
  1633. Co-ordination of Regulatory Enforcement (Regulatory Functions in Scotland and Northern Ireland) Order 2009
  1634. 100Paragraph 100
  1635. Single Use Carrier Bags Charge (Wales) Regulations 2010
  1636. 101Paragraph 101
  1637. Part 6: Northern Ireland statutory rules
  1638. Control of Pesticides Regulations (Northern Ireland) 1987
  1639. 102Paragraph 102
  1640. Prison and Young Offenders Centre (Amendment) Rules (Northern Ireland) 1995
  1641. 103Paragraph 103
  1642. Diseases of Animals (Importation of Bird Products) Order (Northern Ireland) 1996
  1643. 104Paragraph 104
  1644. Pharmaceutical Services Regulations (Northern Ireland) 1997
  1645. 105Paragraph 105
  1646. Industrial Pollution Control (Prescribed Processes and Substances) Regulations (Northern Ireland) 1998
  1647. 106Paragraph 106
  1648. Products of Animal Origin (Import and Export) Regulations (Northern Ireland) 1998
  1649. 107Paragraph 107
  1650. Importation of Animal Pathogens Order (Northern Ireland) 1999
  1651. 108Paragraph 108
  1652. Biocidal Products Regulations (Northern Ireland) 2001
  1653. 109Paragraph 109
  1654. Misuse of Drugs Regulations (Northern Ireland) 2002
  1655. 110Paragraph 110
  1656. Control of Substances Hazardous to Health Regulations (Northern Ireland) 2003
  1657. 111Paragraph 111
  1658. Waste Management Licensing Regulations (Northern Ireland) 2003
  1659. 112Paragraph 112
  1660. Health and Personal Social Services (General Medical Services Contracts) Regulations (Northern Ireland) 2004
  1661. 113Paragraph 113
  1662. Nursing Homes Regulations (Northern Ireland) 2005
  1663. 114Paragraph 114
  1664. Residential Care Homes Regulations (Northern Ireland) 2005
  1665. 115Paragraph 115
  1666. Children's Homes Regulations (Northern Ireland) 2005
  1667. 116Paragraph 116
  1668. Healthy Start Scheme and Day Care Food Scheme Regulations (Northern Ireland) 2006
  1669. 117Paragraph 117
  1670. Avian Influenza and Influenza of Avian Origin in Mammals Regulations (Northern Ireland) 2007
  1671. 118Paragraph 118
  1672. Day Care Setting Regulations (Northern Ireland) 2007
  1673. 119Paragraph 119
  1674. Residential Family Centres Regulations (Northern Ireland) 2007
  1675. 120Paragraph 120
  1676. Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations (Northern Ireland) 2007
  1677. 121Paragraph 121
  1678. Specified Animal Pathogens Order (Northern Ireland) 2008
  1679. 122Paragraph 122
  1680. Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009
  1681. 123Paragraph 123
  1682. Private Water Supplies Regulations (Northern Ireland) 2009
  1683. 124Paragraph 124
  1684. Schedule 35Repeals and revocations
  1685. Explanatory note