The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

Type Statutory-Instrument
Publication 2019-04-01
Last updated 2021-08-03
State In force
Department King's Printer of Acts of Parliament
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articles Not indexed
Reform history JSON API

(269A) (1) This regulation applies to a person, other than the holder of a UKMA(UK), UKMA(NI), EU marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration for a medicinal product, who, in the course of a business carried on by that person, sells or supplies, or offers to sell or supply the product, or possesses the product for the purpose of sale or supply in Northern Ireland. (2) A person to whom this regulation applies is guilty of an offence if the person sells or supplies, or offers to sell or supply, the product, or possesses the product for the purpose of sale or supply, in Northern Ireland knowing or having reasonable cause to believe— (a) that a package or package leaflet relating to the medicinal product does not comply with the applicable requirements of this Part, Article 9 of Commission Regulation 2016/161 or Article 28 or 32 of the Paediatric Regulation; or (b) that the product is not accompanied by a package leaflet when one is required by virtue of this Part.

Amendment of regulation 270 (non-compliance with requirements of this Part)

Amendment of regulation 271 (offences: penalties)

209A

In regulation 271 for “268, 269” substitute “268, 268A, 269, 269A”.

Amendment of regulation 273 (child resistant containers for regulated medicinal products)

Insertion of new regulation 284A (Medicines with differing classification status in Great Britain and Northern Ireland)

213A

After regulation 284, insert—

(284A) In the case of a medicinal product for sale or supply in Great Britain where the product concerned is not a prescription only medicine in Great Britain but is either— (a) a prescription only medicine in Northern Ireland; or (b) not authorised for sale or supply in Northern Ireland, any advertisement to the public must include a statement that the medicinal product is not available without a prescription, or is not available for sale or supply, in Northern Ireland (as the case may be).

Amendment of regulation 293 (prohibition of supply to the public for promotional purposes)

Amendment of regulation 294 (general requirements)

214A

In regulation 294, after paragraph (4) insert—

(5) In the case of an advertisement which relates to a medicinal product for sale or supply— (a) in Northern Ireland only, the requirements of this regulation must be met in relation to the product for sale or supply in Northern Ireland, (b) in Great Britain only, the requirements of this regulation must be met in relation to the product for sale or supply in Great Britain, and (c) in the whole of the United Kingdom, the requirements of this regulation must be met in relation to both— (i) the product for sale or supply in Great Britain, and (ii) the product for sale or supply in Northern Ireland.

Amendment of regulation 295 (abbreviated advertisements)

Amendment of regulation 298 (free samples for persons qualified to prescribe or supply medicinal products)

215A

In regulation 298, for paragraph (5)(a) substitute—

(a) is no larger than the smallest presentation of the product that is available for sale— (i) in the case of a medicinal product for sale or supply in Great Britain, in Great Britain, or (ii) in the case of a medicinal product for sale or supply in Northern Ireland, in Northern Ireland;

Amendment of Schedule 30 (particulars for advertisements to persons qualified to prescribe or supply)

Amendment of regulation 299 (medical sales representatives)

Amendment of regulation 305 (invitation to make representations about compatibility)

217A

In regulation 305—

  • (a) for paragraph (3)(a) substitute—

(a) state that the Ministers are minded to make a determination under regulation 306 that the advertisement is incompatible with the prohibitions imposed by Chapter 2 and specify whether the incompatibility is insofar as the advertisement is for publication— (i) in Great Britain; (ii) in Northern Ireland; or (iii) in both Great Britain and Northern Ireland;

  • (b) in paragraph (4), after “the advertisement” insert—

— (a) in Great Britain; (b) in Northern Ireland; or (c) in both Great Britain and Northern Ireland

Amendment of regulation 306 (decision about compatibility)

217B

In regulation 306—

  • (a) in paragraph (2), after “Chapter 2” insert—

and specify whether the incompatibility is insofar as the advertisement is for publication— (a) in Great Britain; (b) in Northern Ireland; or (c) in both Great Britain and Northern Ireland

  • (b) in paragraph (4)—
  • (i) in sub-paragraph (a), after “Chapter 2” insert—

insofar as the advertisement is for publication— (i) in Great Britain; (ii) in Northern Ireland; or (iii) in both Great Britain and Northern Ireland

  • (ii) after “no longer applies” insert “in Great Britain, Northern Ireland, or both Great Britain and Northern Ireland (as appropriate)”;
  • (c) in paragraph (5), after “Chapter 2” insert—

insofar as the advertisement is for publication— (a) in Great Britain; (b) in Northern Ireland; or (c) in both Great Britain and Northern Ireland

  • (d) in paragraph (7)(b), after “no longer applies” insert—
  • , and where that original notice related to both Great Britain and Northern Ireland, the new notice may be expressed to apply in relation to either of or both Great Britain and Northern Ireland
  • (e) in paragraph (8), after “the advertisement” insert—

— (a) in Great Britain; (b) in Northern Ireland; or (c) in both Great Britain and Northern Ireland

Amendment of regulation 307 (corrective statement)

217C

In regulation 307—

  • (a) in paragraph (1)(a), after “subject of the notice” insert—

in— (i) Great Britain; (ii) Northern Ireland; or (iii) both Great Britain and Northern Ireland

  • (b) in paragraph (1)(b), after “that advertisement” insert—

in— (i) Great Britain; (ii) Northern Ireland; or (iii) both Great Britain and Northern Ireland

  • (c) in paragraph (2)(a), for “, either in full or in part; and” substitute—

in respect of— (i) Great Britain; (ii) Northern Ireland; or (iii) both Great Britain and Northern Ireland, either in full or in part; and

Amendment of regulation 311 (application for injunction)

217D

In regulation 311—

  • (a) in paragraph (1)(a), for “Chapter 2; and” substitute—

Chapter 2 in respect of— (i) Great Britain; (ii) Northern Ireland; or (iii) both Great Britain and Northern Ireland; and

  • (b) in paragraph (3), after “ the advertisement” insert—

in— (i) Great Britain; (ii) Northern Ireland; or (iii) both Great Britain and Northern Ireland, as the case may be.

Amendment of regulation 335 (contravention due to fault of another person)

224ZA

In regulation 335(6)(b) for “268 and 269” substitute “268, 268A, 269 and 269A”.

Amendment of regulation 336 (warranty as defence)

224ZB

In regulation 336(3)(b) for “268 and 269” substitute “268, 268A, 269 and 269A”.

Amendment of regulation 340 (presumptions)

224ZC

In regulation 340(5) for “268 (offences relating to packaging and package leaflets: authorisation holders), 269 (offences relating to packaging and package leaflets: other persons)” substitute “268 (offences relating to packaging and package leaflets in Great Britain: authorisation holders), 268A (offences relating to packaging and package leaflets in Northern Ireland: authorisation holders), 269 (offences relating to packaging and package leaflets in Great Britain: other persons), 269A (offences relating to packaging and package leaflets in Northern Ireland: other persons)”.

Amendment of Schedule 32 (transitional provisions and savings)

224ZD

In paragraph 3(10) of Schedule 32 for “268 (offences relating to packaging and package leaflets: authorisation holders), 269 (offences relating to packaging and package leaflets: other persons)” substitute “268 (offences relating to packaging and package leaflets in Great Britain: authorisation holders), 268A (offences relating to packaging and package leaflets in Northern Ireland: authorisation holders), 269 (offences relating to packaging and package leaflets in Great Britain: other persons), 269A (offences relating to packaging and package leaflets in Northern Ireland: other persons)”.

Amendment of regulation 341 (decisions under the Human Medicines Regulations 2012)

Insertion of regulation 344A (modifications to deal with serious shortages) and 344B (regulation making powers)

Amendment of regulation 345 (immunity from civil liability)

Amendment of regulation 346 (Secretary of State to carry out a review of certain provisions)

Insertion of new regulation 10A (waiver for advice given to small and medium companies)

1ZA

After regulation 10 insert—

(10A) (1) The fee payable in connection with a meeting mentioned in any of regulations 4 to 10 is waived where the person by whom the fee would otherwise be payable is established in the United Kingdom and is— (a) a small company, or (b) a medium-sized company. (2) In this regulation, “small company” and “medium-sized company” have the same meanings as in sections 382 and 465 of the Companies Act 2006 respectively.

Amendment of regulation 19 (capital fees for applications for variations of authorisations)

Insertion of regulations 19A-19F (fees for plasma master files, vaccine antigen master files, post-authorisation safety studies, major safety reviews, periodic safety update reports and batch testing)

Amendment of regulation 23 (applications for multiple variations)

Insertion of regulation 27A (fee for renewals of a marketing authorisation)

Omission of Part 8 (Capital Fees for Regulatory Assistance Given by the United Kingdom Acting as Reference Member State Relating to the Assessment of Applications for the Renewal of Specified Marketing Authorisations)

Amendment of Schedule 1 (general interpretation provisions)

Amendment of Schedule 2 (capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates)

Amendment of Schedule 4 (periodic fees for licences)

Amendment of Schedule 6 (time for payment of capital fees: small companies)

8A

In Schedule 6, in paragraph 2, for “entry 1(f)” substitute “entry 1(h)”.

Amendment of Schedule 7 (waiver, reduction or refund of capital fees)

Amendment of Schedule 8 (Adjustment, reduction or refund of periodic fees)

Savings

SCHEDULE2A — Insertion of new Schedule 8C (Material to accompany an application for a UK marketing authorisation under the unfettered access route)

1

After Schedule 8B to the Human Medicines Regulations 2012, insert—

SCHEDULE8C (1) A copy of the application submitted in connection with the granting of the EU marketing authorisation or UKMA(NI) which authorises the sale or supply of the medicinal product in Northern Ireland. (2) A copy of all material submitted in support of the application for the EU marketing authorisation or UKMA(NI) which authorises the sale or supply of the medicinal product in Northern Ireland. (3) A copy of the EU marketing authorisation or UKMA(NI) which authorises the sale or supply of the medicinal product in Northern Ireland.

Editorial notes

167

Regulation 8 was amended by S.I. 2013/1855 and 2593, 2015/1503, 2016/186, 190 and 696, 2017/715, 2018/199 and 2019/62.

168

S.I. 2002/618. It was amended by S.I. 2008/2936.

169

Regulation 137 is inserted by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019.

170

OJ No. L 106, 17.4.2001, p. 1, as last amended by Commission Directive (EU) 2018/350.

171

Regulation 69 is inserted by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019.

172

OJ No. L 018, 22.01.2000, p. 1.

173

1977 c. 37. Section 128B was inserted by S.I. 2007/3293 and subsection (2) was amended by S.I.2014/2411.

174

The definition of “import” was inserted by S.I. 2013/1855.

175

The definition of “care home” was inserted by S.I. 2019/62.

176

Paragraph (8) was inserted by S.I. 2013/1855.

177

Regulation A17 was inserted by S.I. 2013/1855.

178

The principles and guidelines are available at: https://www.gov.uk/guidance/eu-guidance-documents-referred-to-in-the-human-medicines-regulations-2012 and a hard copy may be obtained from the Medicines and Healthcare products Regulatory Agency at the address given in the Explanatory Note.

179

Regulation 18 was substituted by S.I. 2013/1855 and further amended by S.I. 2016/186.

180

Regulation 19 was amended by S.I. 2013/1855.

181

1990 c. 37. Schedule 3A was inserted by the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007/1522, regulation 30.

183

Schedule 5 was amended by S.I. 2013/1855.

184

S.I. 2005/50. It was amended by S.I. 2005/1098 and 2898, 2006/2013, 2007/604, 2008/525 and 941, 2009/372 and 3307, 2010/554, 2016/604, 2017/1320 and 2018/231.

185

Sections 33A to 33D were inserted by the Human Fertilisation and Embryology Act 2008, c. 22.

186

Regulation 37 was substituted by S.I. 2013/1855.

187

S.I. 2005/50. It has been amended by S.I. 2005/1098 and 2898, 2006/2013, 2007/604, 2008/525 and 941, 2009/372 and 3307, 2010/554, 2016/604, 2017/1320 and 2018/231.

188

Regulation 38 was amended by S.I. 2015/1503.

189

Regulation 39 was amended by S.I. 2013/1855, 2015/354 and 2019/62.

190

Regulation 42 was amended by S.I. 2013/1855 and 2019/62.

191

Schedule 7 was amended by S.I. 2019/62.

192

Regulation 43 was amended by S.I. 2013/1855 and 2016/186.

193

Regulation 44 was amended by S.I. 2013/1855, 2015/1503 and 2016/186.

194

Regulation 45A was inserted by S.I. 2013/1855.

195

Regulation 45D was inserted by S.I. 2013/1855.

196

Regulation 45E was inserted by S.I. 2013/1855.

197

Regulation 45F was inserted by S.I. 2013/1855.

198

Regulation 45M was inserted by S.I. 2013/1855.

199

Schedule 7A was inserted by S.I. 2013/1855.

200

Regulation 45O was inserted by S.I. 2013/1855.

201

Regulation 48 was amended by S.I. 2014/1878.

202

Regulation 49 was amended by S.I. 2014/1878.

204

Regulation 50 was amended by S.I. 2014/1878.

205

The guidance is available at: https://www.gov.uk/guidance/eu-guidance-documents-referred-to-in-the-human-medicines-regulations-2012 and a hard copy may be obtained from the Medicines and Healthcare products Regulatory Agency at the address given in the Explanatory Note.

206

The guidelines are available at: https://www.gov.uk/guidance/eu-guidance-documents-referred-to-in-the-human-medicines-regulations-2012 and a hard copy may be obtained from the Medicines and Healthcare products Regulatory Agency at the address given in the Explanatory Note.

207

The guidance is available at: https://www.gov.uk/guidance/eu-guidance-documents-referred-to-in-the-human-medicines-regulations-2012 and a hard copy may be obtained from the Medicines and Healthcare products Regulatory Agency at the address given in the Explanatory Note.

208

Schedule 8 was amended by S.I. 2013/1855.

209

Schedule 8A was inserted by S.I. 2014/1878.

210

S.I. 2002/618, as amended by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019.

211
212
213
214
215

S.I. 2002/618, as amended by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019.

216

Regulation 59 was amended by S.I. 2014/1878.

218

Regulation 65A was inserted by S.I. 2014/1878.

219

The guidelines are available at: https://www.gov.uk/guidance/eu-guidance-documents-referred-to-in-the-human-medicines-regulations-2012 and a hard copy may be obtained from the Medicines and Healthcare products Regulatory Agency at the address given in the Explanatory Note.

220

Regulation 66A was inserted by S.I. 2014/1878.

221

Regulation 68 was amended by S.I. 2013/1855 and 2014/1878.

222

Regulation 69 was amended by S.I. 2014/1878.

223

Regulation 71 was amended by S.I. 2014/1878.

224

Regulation 73 was amended by S.I. 2013/2593: regulation 3 inserted sub-paragraphs (5A) to (5C).

225

Regulation 75 was amended by S.I. 2014/1878.

226

1990 c. 37. Sections 33A to 33D were inserted by the Human Fertilisation and Embryology Act 2008, c. 22.

227

S.I. 2005/50. It was amended by S.I. 2005/1098 and 2898, 2006/2013, 2007/604, 2008/525 and 941, 2009/372 and 3307, 2010/554, 2016/604, 2017/1320 and 2018/231.

229

Regulation 97 was substituted by S.I. 2014/1878.

230

Regulation 110 was amended by S.I.2013/1855.

231

Paragraph (3A) was inserted by S.I. 2013/2593.

232

Regulation 135 was amended by S.I. 2013/1855.

233

Regulation 142 was amended by S.I. 2013/2593.

234

Regulation 177 was amended by S.I. 2013/1855 and 2014/1878.

235

Regulation 182 was amended by S.I. 2013/1855.

236

Regulation 195 was amended by S.I. 2014/1878.

237

Regulation 206 was amended by S.I. 2013/1855.

238

Regulation 210A was inserted by S.I. 2013/1855.

239

Regulation 213 was amended by S.I. 2013/235 and 2014/490 and 1878.

240

The definition was substituted by S.I. 2014/1878.

241

Regulation 214 was amended S.I. 2013/1855, 2014/490, 2016/186 and 2018/199.

242

Regulation 217 was amended by S.I. 2014/490.

243

Regulation 217A was inserted by S.I. 2014/490.

244

Regulation 218 was amended by S.I. 2014/490 and 1878 and 2015/903.

245

Regulation 219 was amended by S.I. 2015/903 and 2016/696.

246

Regulation 219A was amended by S.I. 2015/903.

247

Schedule 17 was amended by S.I. 2014/1878, 2015/1503, 2016/186 and 2017/715,

248

1990 c. 37. Sections 33A to 33D were inserted by the Human Fertilisation and Embryology Act 2008, c. 22.

249

S.I. 2005/50. It has been amended by S.I. 2005/1098 and 2898, 2006/2013, 2007/604, 2008/525 and 941, 2009/372 and 3307, 2010/604, 2017/1320 and 2018/231.

251

1990 c. 37. Schedule 3A was inserted by the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007/1522, regulation 30.

253

Schedule 27 was amended by S.I. 2014/1878.

254

Regulation 268 was amended by S.I. 2019/62.

255

Regulation 269 was amended by S.I. 2015/903 and 2019/62.

256

Regulation 323 was amended S.I. 2019/62.

257

Regulation 327 was amended by S.I. 2013/1855 and 2019/62.

258

The guidelines are available at: https://www.gov.uk/guidance/eu-guidance-documents-referred-to-in-the-human-medicines-regulations-2012 and a hard copy may be obtained from the Medicines and Healthcare products Regulatory Agency at the address given in the Explanatory Note.

259

Regulation 346 was substituted by S.I. 2013/1855 and then amended by S.I. 2013/2593, 2014/490 and 1878, 2015/323, 903 and 1503, 2016/186, 2017/715, 2018/199 and 2019/62.

260

Section 465 was amended by S.I. 2015/980

264

1986 c. 14, as amended by S.I. 2012/3039.

273

International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals. N Engl J Med 1997; 336:309-15.

274

OJ No. L 387, 27.12.2006, p. 1.

275

OJ No. L 92, 30.3.2006, p. 6.

280

S.I. 1977/670. Article 2 was amended by S.I. 1990/2487, 1997/856, 2008/548 and 2012/1809.

281

S.I. 1997/1830. Article 5(1) was amended by S.I. 2012/1916.

283

Article 1 was amended by S.I. 2008/548 and 2012/1809.

284

Article 4 was amended by S.I. 2008/548 and 2012/1916.

286

Article 1 was amended by S.I. 2008/548 and 2012/1809.

287

Article 3 was amended by S.I. 2008/548 and 2012/1916.

288

S.I. 2005/50. Regulation 1A was inserted by S.I. 2019/4.

289

S.I. 2007/2785. Regulation 3(1)(a) was substituted by S.I. 2018/352.

291

Article 1 was amended by S.I. 2012/1809.

292

Article 3 was amended by S.I. 2012/1916.

296
300

OJ No, L 189, 27.6.2014, p. 112.

301

Reg. 30 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

302

Reg. 123 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

303

Reg. 182 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

304

Reg. 1 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

305

Sch. 1 para. 1 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

306

Sch. 1 para. 11 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

307

Sch. 1 para. 2 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

308

Sch. 1 para. 3 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

309

Sch. 1 para. 4 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

310

Sch. 1 para. 5 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

311

Sch. 1 para. 6 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

312

Sch. 1 para. 7 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

313

Sch. 1 para. 8 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

314

Sch. 1 para. 9 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

315

Sch. 1 para. 10 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

316

Sch. 8 para. 1 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

317

Sch. 8 para. 2 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

318

Sch. 8 para. 3 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

319

Sch. 8 para. 4 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

320

Sch. 8 para. 5 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

321

Sch. 8 para. 6 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

322

Sch. 8 para. 8 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

323

Sch. 8 para. 9 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

324

Sch. 8 para. 10 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

325

Sch. 8 para. 11 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

326

Sch. 8 para. 12 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

327

Sch. 8 para. 13 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

328

Sch. 8 para. 14 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

329

Sch. 8 para. 15 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

330

Sch. 8 para. 16 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

331

Sch. 9 para. 1 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

332

Reg. 4 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

333

Reg. 5 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

334

Reg. 7 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

335

Reg. 10 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

336

Reg. 13 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

337

Reg. 14 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

338

Reg. 15 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

339

Reg. 16 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

340

Reg. 17 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

341

Reg. 18 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

342

Reg. 19 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

343

Reg. 20 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

344

Reg. 22 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

345

Reg. 23 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

346

Reg. 24 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

347

Reg. 25 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

348

Reg. 26 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

349

Reg. 27 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

350

Reg. 28 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

351

Reg. 29 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

352

Reg. 32 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

353

Reg. 33 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

354

Reg. 35 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

355

Reg. 36 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

356

Reg. 37 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

357

Reg. 38 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

358

Reg. 39 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

359

Reg. 40 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

360

Reg. 41 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

361

Reg. 42 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

362

Reg. 43 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

363

Reg. 44 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

364

Reg. 45 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

365

Reg. 46 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

366

Reg. 47 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

367

Reg. 48 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

368

Reg. 49 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

369

Reg. 50 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

370

Reg. 51 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

371

Reg. 52 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

372

Reg. 53 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

373

Reg. 55 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

374

Reg. 59 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

375

Reg. 61 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

376

Reg. 62 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

377

Reg. 63 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

378

Reg. 64 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

379

Reg. 65 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

380

Reg. 67 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

381

Reg. 68 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

382

Reg. 70 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

383

Reg. 71 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

384

Reg. 72 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

385

Reg. 74 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

386

Reg. 75 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

387

Reg. 76 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

388

Reg. 77 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

389

Reg. 78 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

390

Reg. 79 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

391

Reg. 80 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

392

Reg. 82 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

393

Reg. 83 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

394

Reg. 87 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

395

Reg. 89 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

396

Reg. 94 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

397

Reg. 98 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

398

Reg. 99 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

399

Reg. 101 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

400

Reg. 102 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

401

Reg. 103 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

402

Reg. 104 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

403

Reg. 105 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

404

Reg. 106 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

405

Reg. 108 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

406

Reg. 109 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

407

Reg. 110 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

408

Reg. 111 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

409

Reg. 112 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

410

Reg. 115 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

411

Reg. 116 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

412

Reg. 117 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

413

Reg. 118 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

414

Reg. 119 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

415

Reg. 120 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

416

Reg. 121 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

417

Reg. 122 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

418

Reg. 124 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

419

Reg. 125 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

420

Reg. 126 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

421

Reg. 128 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

422

Reg. 130 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

423

Reg. 133 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

424

Reg. 134 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

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