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

PART 14 U.K. Amendment of Part 13 (packaging and leaflets)

Amendment of regulation 257 (packaging requirements: general) U.K.

198.—(1) Regulation 257 is amended as follows.

(2) In paragraph (6), after “this regulation,” insert “ regulation 257C [F1 where the product is for sale or supply in Great Britain only],”.

(3) After paragraph (7) insert—

“(8) Nothing in this regulation applies to the outer or immediate packaging of an advanced therapy medicinal product [F2 for sale or supply in Great Britain only].”.

Textual Amendments

F1 Words in reg. 198(2) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 152(a)

F2 Words in reg. 198(3) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 152(b)

Commencement Information

I1 Reg. 198 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

[F3 Amendment of regulation 257A (packaging requirements: medicinal products required to bear safety features) U.K.

199.   In regulation 257A, after “either fully or partially,” insert “from a product to which Article 54a of the 2001 Directive applies”.

Textual Amendments

F3 Regs. 199, 199A substituted for reg. 199 (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 153

Commencement Information

I2 Reg. 199 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Amendment of regulation 257B (transitional arrangements) U.K.

199A.   In regulation 257B, after “unless the product” insert “is one to which Article 54a of the 2001 Directive applies and”.]

Textual Amendments

F3 Regs. 199, 199A substituted for reg. 199 (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 153

Commencement Information

I3 Reg. 199A in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Insertion of regulations 257C (packaging requirements: advanced therapy medicinal products) and 257D and 257E (guidance and regulations in relation to packing, leaflets and labelling) U.K.

200.  After regulation 257, insert—

“Packaging requirements: advanced therapy medicinal products

257C.— (1) The information specified in Part 4 of Schedule 24 must appear—

(a) on the outer packaging of an advanced therapy medicinal product [F4 for sale or supply in Great Britain only] (other than an exempt advanced therapy medicinal product); and

(b) on the immediate packaging [F5 of that product], unless paragraph (2) or (3) applies to the packaging.

(2) This paragraph applies to the immediate packaging if the packaging is in the form of a blister pack and is placed in outer packaging which complies with the requirements of Part 4 of Schedule 24.

(3) This paragraph applies to immediate packaging if the packaging is too small to display the information required by Part 4 of Schedule 24.

(4) The information specified in Part 5 of Schedule 24 must appear on immediate packaging to which paragraph (2) or (3) applies.

Guidance as to packaging and package leaflets

[F6 257D.— ( 1) The licensing authority may publish guidance on packaging and package leaflets applicable to products for sale or supply in the whole United Kingdom or parts of the United Kingdom, as appropriate.

(2) Guidance published under paragraph (1) may, in particular, include—

(a) the wording of certain special warnings for certain categories of medicinal products;

(b) the particular information needs relating to products that are a pharmacy medicine;

(c) the legibility of particulars on the labelling and package leaflet;

(d) the methods of identification and authentication of medicinal products;

(e) the list of excipients which must feature on the labelling of medicinal products and the way in which these excipients must be indicated.

(3) Until such time as the licensing authority publishes guidance under paragraph (1), any guidance published by the Commission pursuant to Article 65 of the 2001 Directive, insofar as that guidance was in force immediately before IP completion day, continues to apply as if it had been published by the licensing authority under paragraph (1).]

Regulation-making power as to certain forms of labelling

257E.   The Ministers may by regulations require the use of certain forms of labelling of a medicinal product in order to make it possible to ascertain—

(a) the price of the medicinal product;

(b) any reimbursement conditions of the National Health Service;

(c) the legal status for supply to the patient in accordance with regulation 5 (classification), insofar as not already provided for in Schedule 25;

(d) authenticity and identification of the medicinal product in accordance with Article 54a(5) of the 2001 Directive.”.

Textual Amendments

F4 Words in reg. 200 inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 154(a)(i)

F5 Words in reg. 200 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 154(a)(ii)

F6 Words in reg. 200 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 154(b)

Commencement Information

I4 Reg. 200 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Amendment of Schedule 24 (packaging information requirements) U.K.

201.—(1) Schedule 24 is amended as follows.

(2) In paragraph 7(b), for “published pursuant to Article 65 of the 2001 Directive” substitute “ published under regulation 257D [F7 in the case of products for sale or supply in Great Britain, or in the case of products for sale or supply in Northern Ireland, any guidance published pursuant to Article 65 of the 2001 Directive or under regulation 257D that is applicable to such products.]”.

(3) In paragraphs 15, 16 and 23, [F8 for “marketing authorisation,” substitute “UK marketing authorisation, EU marketing authorisation”.].

F9 (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) After Part 3 insert—

“PART 4 U.K. Outer and immediate packaging: advanced therapy medicinal products [F10 for sale or supply in Great Britain only]

34.   The name of the advanced therapy medicinal product which is the international non-proprietary name, or if none, the common name.

35.   Where appropriate, whether the product is intended for babies, children or adults.

36.   The expiry date in clear terms including the year and month and, if applicable, day.

37.   A description of the active substance, expressed qualitatively and quantitatively.

38.   Where the product contains tissues and cells of human or animal origin—

(a) a statement that the product contains such cells or tissues; and

(b) a short description of the cells or tissues and of their specific origin, including the species of animal in cases on non-human origin.

39.   The pharmaceutical form and the contents by weight, volume or number of doses of the product.

40.   A list of excipients, including preservative systems.

41.   The method of use, application, administration or implantation and, if appropriate, the route of administration, with space provided for the prescribed dose to be indicated.

42.   A special warning that the product is to be stored out of the sight and reach and children.

43.   Any special warning necessary for the particular product.

44.   Any special storage precautions.

45.   Specific precautions relating to the disposal of the unused product or of waste derived from the product and, where appropriate, reference to any appropriate collection system.

46.   The name and address of the holder of the UK marketing authorisation and, where applicable, the name of the representative appointed by the holder to represent him.

47.   The UK marketing authorisation number.

48.   The manufacturer's batch number.

49.   The unique donation code assigned by a tissue establishment pursuant to—

(a) paragraph 1 of Schedule 3A to the Human Fertilisation and Embryology Act 1990 M1 , as regards human gametes and embryos; and

(b) paragraph 1 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007 M2 , as regards other human tissues and cells.

50.   Where the exempt advanced therapy medicinal product is for autologous use, the unique patient identifier and the words “for autologous use only”.

PART 5 U.K. Immediate packaging: blister packs and small packaging (advanced therapy medicinal products [F11 for sale or supply in Great Britain only])

51.   The information specified in Part 2.

52.   The unique donation code assigned by a tissue establishment pursuant to—

(a) paragraph 1 of Schedule 3A to the Human Fertilisation and Embryology Act 1990, as regards human gametes and embryos; and

(b) paragraph 1 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007, as regards other human tissues and cells.

53.   Where the exempt advanced therapy medicinal product is for autologous use, the unique patient identifier and the words “for autologous use only”.”

Textual Amendments

F7 Words in reg. 201(2) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 155(a)

F8 Words in reg. 201(3) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 155(b)

F9 Reg. 201(4) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 155(c)

F10 Words in reg. 201(5) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 155(d)(i)

F11 Words in reg. 201(5) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 155(d)(ii)

Commencement Information

I5 Reg. 201 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M1 1990 c. 37. Schedule 3A was inserted by the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007/1522, regulation 30.

M2 S.I. 2007/1523.

Amendment of regulation 259 (packaging requirements: information for blind and partially sighted patients) U.K.

202.  In regulation 259(2), [F12 for “marketing authorisation,” substitute “UK marketing authorisation, EU marketing authorisation”.]

Textual Amendments

F12 Words in reg. 202 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 156

Commencement Information

I6 Reg. 202 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Amendment of regulation 260 (package leaflets) U.K.

203.—(1) Regulation 260 is amended as follows.

(2) After paragraph (1) insert—

“(1A) If the medicinal product is an advanced therapy medicinal product [F13 for sale or supply in Great Britain only] (other than an exempt advanced therapy medicinal product), the package leaflet must contain the information specified in Part 3 of Schedule 27 in the order specified in that Part.”.

(3) In paragraph (2), after “Part 2 of that Schedule)” insert “ , or where the product is an advanced therapy medicinal product [F14 for sale or supply in Great Britain only], the information specified in Part 3 of that Schedule, ”.

(4) In paragraph (3), for “marketing authorisationF15 ...” substitute “ UK marketing authorisation [F16 , EU marketing authorisation,] ”.

Textual Amendments

F13 Words in reg. 203(2) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 157(a)

F14 Words in reg. 203(3) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 157(b)

F15 Words in reg. 203(4) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 157(c)(i)

F16 Words in reg. 203(4) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 157(c)(ii)

Commencement Information

I7 Reg. 203 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Amendment of Schedule 27 (package leaflets) U.K.

204.—(1) Schedule 27 M3 is amended as follows.

(2) In paragraph 8(c)(ii), for “Article 65 of the 2001 Directive”, substitute “ published under regulation 257D [F17 in the case of products for sale or supply in Great Britain, or in the case of products for sale or supply in Northern Ireland, any guidance published pursuant to Article 65 of the 2001 Directive or under regulation 257D that is applicable to such products.] ”.

(3) In paragraph 11(f), [F18 for “marketing authorisation,” substitute “UK marketing authorisation, EU marketing authorisation”.]

(4) [F19 In] paragraph 12 [F20 after “ Where the product ” insert "is authorised for sale or supply in Northern Ireland and”.] .

(5) In paragraph 13—

(a) [F21 after] “Article 23 of Regulation (EC) No 726/2004" [F22 insert “in the case of products for sale or supply in Northern Ireland, or the list referred to in regulation 202A, in the case of products for sale or supply in Great Britain,”;] ;

(b) before “statement”, insert “ symbol and ”; and

(c) before “This”, insert “ ▼ ”.

(6) At the end insert—

“Part 3 U.K. Advanced therapy medicinal products [F23 for sale or supply in Great Britain only]

18.   The name of the advanced therapy medicinal product.

19.   Where appropriate, whether the product is intended for babies, children or adults.

20.   The common name of the advanced therapy medicinal product.

21.   The therapeutic group, or type of activity, of the product, in terms easily comprehensible for the patient.

22.   Where the product contains cells or tissues, a description of those cells or tissues and of their specific origin, including the species of animal in cases of non-human origin.

23.   Where the product contains medical devices or active implantable medical devices, a description of those devices and their specific origin.

24.   The product's therapeutic indications.

25.   A list of information which is necessary before the medicinal product is taken or used, including—

(a) contra-indications;

(b) appropriate precautions for use;

(c) interactions with other medicinal products which may affect the action of the product;

(d) interactions with other substances, including alcohol, tobacco and foodstuffs which may affect the action of the product;

(e) special warnings; if any, relating to the product.

26.   The list mentioned in paragraph 25 must—

(a) take into account the special requirements of particular categories of users (including, in particular, children, pregnant or breastfeeding women, the elderly and persons with specific pathological conditions);

(b) mention, if appropriate, possible effects on the ability to drive vehicles or operate machinery; and

(c) list any excipients—

(i) if knowledge of the excipients is important for the safe and effective use of the product; and

(ii) the excipients are included in the guidance published under regulation 257D.

27.   Instructions for proper use of the product including in particular—

(a) the dosage;

(b) the method of use, application, administration or implantation and, if necessary, the route of administration;

(c) the frequency of administration (including, if necessary, specifying the times at which the product may or must be administered);

(d) the duration of treatment if this is to be time limited;

(e) symptoms of an overdose and the action, if any, to be taken in the case of an overdose;

(f) what to do if one or more doses have not been taken;

(g) a specific recommendation to consult a doctor or pharmacist, as appropriate, for further explanation of the use of the product.

28.   A description of the adverse reactions which may occur in normal use of the medicinal product and, if necessary, the action to be taken in such a case.

29.   A reference to the expiry date printed on the packaging of the product with—

(a) a warning against using the product after that date;

(b) if appropriate, details of special storage precautions to be taken;

(c) if necessary, a warning concerning visible signs of deterioration;

(d) the full qualitative and quantitative composition;

(e) the name and address of the UK marketing authorisation holder and, if applicable, the name of the holder's appointed representative; and

(f) the name and address of the manufacturer.

30.   The date on which the package leaflet was last revised.”.

Textual Amendments

F17 Words in reg. 204(2) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 158(a)

F18 Words in reg. 204(3) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 158(b)

F19 Word in reg. 204(4) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 158(c)(i)

F20 Words in reg. 204(4) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 158(c)(ii)

F21 Word in reg. 204(5)(a) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 158(d)(i)

F22 Words in reg. 204(5)(a) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 158(d)(ii)

F23 Words in reg. 204(6) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 158(e)

Commencement Information

I8 Reg. 204 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M3 Schedule 27 was amended by S.I. 2014/1878.

Prospective

Amendment of regulation 266 (language requirements etc) U.K.

F24 205.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F24 Reg. 205 omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 159

Amendment of regulation 267 (submission of mock-ups of packaging and leaflets to licensing authority) U.K.

206.  In regulation 267 [F25 before “marketing authorisation”, in each place where it occurs, insert “UK”.]

Textual Amendments

F25 Words in reg. 206 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 160

Commencement Information

I9 Reg. 206 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Amendment of regulation 268 (offence relating to packaging and package leaflets) U.K.

207.—(1) Regulation 268 M4 is amended as follows.

[F26 (1A) In the heading to the regulation, after “packaging and package leaflets” insert “in Great Britain”.]

[F27 (2) In paragraph (1)—

(a) for “marketing authorisation, Article 126a authorisation” substitute “UKMA(UK), UKMA(GB)”;

(b) after “the purpose of sale or supply” insert “, in Northern Ireland”.]

(3) In paragraph (2)(a)—

(a) for “Article 28 or 32 of the Paediatric Regulation” substitute “ regulation 50C(4), 50D(8) or 58A(2)(b) ”; and

(b) omit “, Article 9 of Commission Regulation 2016/161”.

Textual Amendments

F26 Reg. 207(1A) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 161(a)

F27 Reg. 207(2) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 161(b)

Commencement Information

I10 Reg. 207 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M4 Regulation 268 was amended by S.I. 2019/62.

[F28 Insertion of new regulation 268A (offence relating to packaging and package leaflets in Northern Ireland: holder of authorisation etc) U.K.

207A.   After regulation 268 insert—

“Offence relating to packaging and package leaflets in Northern Ireland: holder of authorisation etc

268A.— (1) This regulation applies to 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 sells or supplies, offers to sell or supply, or possesses for the purpose of sale or supply, in Northern Ireland, a medicinal product to which the authorisation, certificate or registration relates.

(2) A person to whom this regulation applies is guilty of an offence if—

(a) a package or package leaflet relating to the 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) the product is not accompanied by a package leaflet when one is required by virtue of this Part.”.]

Textual Amendments

F28 Reg. 207A inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 162

Commencement Information

I11 Reg. 207A in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Amendment of regulation 269 (offences relating to packaging and package leaflets: other persons) U.K.

208.—(1) Regulation 269 M5 is amended as follows.

[F29 (1A) In the heading to the regulation, after “packaging and package leaflets” insert “in Great Britain”.]

[F30 (2) In paragraph (1)—

(a) for “marketing authorisation, Article 126a authorisation” substitute “UKMA(UK), UKMA(GB)”;

(b) after “the purpose of sale or supply” insert “, in Great Britain”.]

[F31 (2A) In paragraph (2), after “for the purpose of sale or supply,” insert “in Great Britain”.]

(3) In paragraph (2)(a)—

(a) for “Article 28 or 32 of the Paediatric Regulation” substitute “ regulation 50C(4), 50D(8) or 58A(2)(b) ”; and

(b) omit “, Article 9 of Commission Regulation 2016/161”.

Textual Amendments

F29 Reg. 208(1A) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 163(a)

F30 Reg. 208(2) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 163(b)

F31 Reg. 208(2A) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 163(c)

Commencement Information

I12 Reg. 208 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M5 Regulation 269 was amended by S.I. 2015/903 and 2019/62.

[F32 Insertion of new regulation 269A (offences relating to packaging and package leaflets in Northern Ireland: other persons) U.K.

208A.   After regulation 269 insert—

“Offences relating to packaging and package leaflets in Northern Ireland: other persons

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.”.]

Textual Amendments

F32 Reg. 208A inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 164

Commencement Information

I13 Reg. 208A in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

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

209.  In regulation 270(1) and (2), [F33 for “marketing authorisation,” substitute “UK marketing authorisation, EU marketing authorisation,].

Textual Amendments

F33 Words in reg. 209 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 165

Commencement Information

I14 Reg. 209 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

[F34 Amendment of regulation 271 (offences: penalties) U.K.

209A.   In regulation 271 for “268, 269” substitute “268, 268A, 269, 269A”.]

Textual Amendments

F34 Reg. 209A inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 166

Commencement Information

I15 Reg. 209A in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

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

210.—(1) Regulation 273 is amended as follows.

(2) In paragraph (2), for sub-paragraph (b) substitute—

“(b) any specification for non-reclosable child resistant packaging that the licensing authority is satisfied is of an equivalent or higher technical specification to that specified in sub-paragraph (a).”.

(3) In paragraph (3), for sub-paragraph (b) substitute—

“(b) any specification for reclosable child resistant packaging that the licensing authority is satisfied is of an equivalent or higher technical specification to that specified in sub-paragraph (a).”.

Commencement Information

I16 Reg. 210 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1