OpenLegislation

The Human Medicines Regulations 2012 in Northern Ireland

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.

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