Medicinal Products (Safety Features on Packaging) Regulations 2022.
Statutory Instruments
Source: Statutory Instruments

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paragraphs: (1) These Regulations may be cited as the Medicinal Products (Safety Features on Packaging) Regulations 2022.
(2) The Regulations of 2019 and these Regulations may be cited together as the Medicinal Products (Safety Features on Packaging) Regulations 2019 and 2022.
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paragraphs: (1) In these Regulations—
(2) A word or expression that is used in these Regulations and is also used in the EU Regulation or the Directive has, unless the context otherwise requires, the same meaning in these Regulations that it has in the EU Regulation or the Directive.
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paragraphs: These Regulations apply to—
(a) medicinal products subject to prescription other than those listed in Annex I to the EU Regulation, and
(b) medicinal products which are not subject to prescription and are listed in Annex II to the EU Regulation.
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paragraphs: A person who places on the market a medicinal product which does not have a unique identifier placed on its packaging is guilty of an offence.
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paragraphs: A person who places on the market a medicinal product with a unique identifier which fails to comply with the technical specifications set out in Article 4 of the EU Regulation is guilty of an offence.
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paragraphs: A person who places on the market a medicinal product with a unique identifier encoded otherwise than in accordance with Article 5 of the EU Regulation is guilty of an offence.
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paragraphs: A person who places on the market a medicinal product with a unique identifier which does not comply with the quality of printing requirements set out in Article 6 of the EU Regulation is guilty of an offence.
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paragraphs: (1) Subject to paragraph (2), a person who places on the market a medicinal product which does not have the data elements listed in Article 7(1) of the EU Regulation (other than subparagraph (c) thereof) on its packaging in human-readable format is guilty of an offence.
(2) Paragraph (1) shall not apply where the sum of the two longest dimensions of the packaging equals or is less than 10 centimetres.
(3) Subject to paragraph (4), a person who places on the market a medicinal product which does not have the human-readable data elements referred to in paragraph (1) adjacent to the two-dimensional barcode carrying the unique identifier is guilty of an offence.
(4) Paragraph (3) shall not apply where the dimensions of the packaging of the medicinal product do not allow for the human-readable data elements to be adjacent to the two dimensional barcode.
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paragraphs: A person who places on the market a medicinal product which has on its packaging, for the purpose of identification and verification of authenticity, any visible two-dimensional barcode other than the two-dimensional barcode carrying the unique identifier, is guilty of an offence.
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paragraphs: (1) Subject to paragraph (2), a person who further distributes or supplies to the public a medicinal product bearing a unique identifier which has been decommissioned is guilty of an offence.
(2) Paragraph (1) shall not apply where one of the exceptions listed in Article 12 of the EU Regulation applies.
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paragraphs: (1) Subject to paragraph (2), a person who reverses the status of a decommissioned unique identifier is guilty of an offence.
(2) Paragraph (1) shall not apply where the conditions listed in Article 13(1) of the EU Regulation are fulfilled.
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paragraphs: A person who places on the market a medicinal product and fails to comply with the record keeping requirements set out in Article 15 of the EU Regulation in respect of such medicinal product is guilty of an offence.
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paragraphs: A manufacturer who fails to perform verifications required under Articles 16 and 17 of the EU Regulation before removing, covering (either fully or partially) or replacing safety features is guilty of an offence.
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paragraphs: (1) Where a manufacturer has reason to believe that—
(a) the packaging of a medicinal product has been tampered with, or
(b) the verification of the safety features on a medicinal product indicates that the product may not be authentic,
(i) places the medicinal product on the market, or
(ii) fails to immediately inform the Authority after forming such belief.
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paragraphs: (1) Subject to paragraph (2), a wholesaler in physical possession of a medicinal product referred to in Article 20(a) or (b) of the EU Regulation who fails to verify the authenticity of the unique identifier on the product is guilty of an offence.
(2) Paragraph (1) shall not apply in the case of a medicinal product referred to in Article 20(b) of the EU Regulation in any of the situations listed in Article 21 of the EU Regulation.
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paragraphs: A wholesaler in physical possession of a medicinal product referred to in Article 22 of the EU Regulation who fails to verify the authenticity of, and decommission, the unique identifier of the product is guilty of an offence.
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paragraphs: In the case of a shipment of medicinal products manufactured and labelled for the United Kingdom market, a wholesaler who fails to perform adequate verifications to ensure that the shipment complies with the requirement to bear safety features under Article 54a(1) of Directive 2001/83/EC when received from—
(a) the manufacturer,
(b) the marketing authorisation holder, or
(c) a wholesaler who is designated by the marketing authorisation holder, by means of a written contract, to store and distribute the products covered by his marketing authorisation on his behalf,
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paragraphs: (1) Where a wholesaler has reason to believe that—
(a) the packaging of a medicinal product has been tampered with, or
(b) the verification of the safety features on a medicinal product indicates that the product may not be authentic,
(i) distributes the medicinal product, or
(ii) fails to immediately inform the Authority after forming such belief.
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paragraphs: A wholesaler who fails to comply with Regulation 5(2) of the Regulations of 2019, where applicable, is guilty of an offence.
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paragraphs: (1) Subject to paragraph (2), a person authorised to supply medicinal products to the public who fails to verify the safety features and decommission the unique identifier of any medicinal product bearing safety features, in accordance with Article 25(3) of the EU Regulation—
(a) before supplying that product to the public,
(b) in the case of a person operating within a healthcare institution, between the delivery of the product to the healthcare institution and the sale or supplying of it to the public,
(c) in the case of a medicinal product that cannot be returned to the wholesaler or manufacturer, while the product is in his or her physical possession,
(d) in the case of a medicinal product that is requested as a sample by the Authority or the Society, prior to providing such sample,
(e) in the case of a medicinal product that he or she supplies for subsequent use as authorised investigational medicinal products or authorised auxiliary medicinal products as defined in Article 2(2)(9) and (10) of Regulation (EU) No. 536/2014 of the European Parliament and of the Council of 16 April 20145 , at the time of such supply,
(f) in the case of the supply of only part of a pack of a medicinal product the unique identifier of which is not decommissioned, when the pack is opened for the first time, or
(g) where there are technical problems preventing verification and decommissioning, as soon as those problems are solved,
(2) Paragraph (1) shall not apply—
(a) in the case of a medicinal product provided, to a person authorised or entitled to supply medicinal products to the public, as a free sample in accordance with Article 96 of the Directive, and
(b) where the obligation to verify and decommission is on the wholesaler pursuant to Article 5(2) of the Regulations of 2019.
(3) Where paragraph (2)(b) applies, a person authorised to supply medicinal products to the public who fails to verify the authenticity of the anti-tampering device at the time the medicinal product is supplied to the public is guilty of an offence.
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paragraphs: (1) Where a person authorised to supply medicinal products to the public has reason to believe that—
(a) the packaging of a medicinal product has been tampered with, or
(b) the verification of the safety features on a medicinal product indicates that the product may not be authentic,
(i) supplies the medicinal product, or
(ii) fails to immediately inform the Authority after forming such belief.
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paragraphs: (1) Subject to paragraph (2), a marketing authorisation holder who fails to—
(a) upload the information referred to in Article 33(2) of the EU Regulation to the repositories system, in the manner required under Article 33(3) of the EU Regulation, before releasing the medicinal product for sale or distribution by the manufacturer, or
(b) keep such information up to date thereafter,
(2) Paragraph (1) shall not apply in the case of parallel imported or parallel distributed medicinal products bearing an equivalent unique identifier for the purposes of complying with Article 47a of the Directive.
(3) In the case of parallel imported or parallel distributed medicinal products bearing an equivalent unique identifier for the purposes of complying with Article 47a of the Directive, if the person responsible for placing the products on the market fails to—
(a) upload the information referred to in Article 33(2) of the EU Regulation to the repositories system, in the manner required under Article 33(3) of the EU Regulation, before releasing the medicinal product for sale or distribution by the manufacturer, or
(b) keep such information up to date thereafter,
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paragraphs: For each batch of repackaged or relabelled packs of a medicinal product on which equivalent unique identifiers were placed for the purposes of complying with Article 47a of the Directive, the person responsible for placing the medicinal product on the market is guilty of an offence if he or she fails to upload to the hub—
(a) the batch number or numbers of the packs which are to be repackaged or relabelled and of the unique identifiers on those packs, or
(b) the batch number of the batch resulting from the repackaging or relabelling operations and the equivalent unique identifiers in that batch.
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paragraphs: (1) Subject to paragraph (2), where a medicinal product is recalled, withdrawn or stolen, and the marketing authorisation holder fails to take the measures set out in Article 40 of the EU Regulation, the marketing authorisation holder is guilty of an offence.
(2) Paragraph (1) shall not apply in the case of parallel imported or parallel distributed medicinal products bearing an equivalent unique identifier for the purposes of complying with Article 47a of the Directive.
(3) In the case of parallel imported or parallel distributed medicinal products bearing an equivalent unique identifier for the purposes of complying with Article 47a of the Directive, where a medicinal product is recalled, withdrawn or stolen, and the person responsible for placing the product on the market fails to take the measures set out in Article 40 of the EU Regulation, that person is guilty of an offence.
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paragraphs: A marketing authorisation holder intending to supply a medicinal product as a free sample in accordance with Article 96 of the Directive, where that product bears the safety features, who fails to—
(a) indicate it as a free sample in the repositories system, and
(b) ensure the decommissioning of its unique identifier before providing it to the persons qualified to prescribe it,
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paragraphs: (1) Subject to paragraph (2), a marketing authorisation holder who uploads unique identifiers in the repositories system before having removed from therein older unique identifiers containing the same product code and serial number as the unique identifiers being uploaded is guilty of an offence.
(2) Paragraph (1) shall not apply in the case of parallel imported or parallel distributed medicinal products bearing an equivalent unique identifier for the purposes of complying with Article 47a of the Directive.
(3) In the case of parallel imported or parallel distributed medicinal products bearing an equivalent unique identifier for the purposes of complying with Article 47a of the Directive, where the person responsible for placing those medicinal products on the market uploads unique identifiers in the repositories system before having removed from therein older unique identifiers containing the same product code and serial number as the unique identifiers being uploaded, that person is guilty of an offence.
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paragraphs: A legal entity managing a repository in the State, as part of the repositories system, which fails to perform any of the actions listed in Article 37 of the EU Regulation is guilty of an offence.
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paragraphs: (1) Subject to paragraph (2), a legal entity managing a repository in the State, as part of the repositories system, which accesses an audit trail (as referred to in Article 35(1)(g) of the EU Regulation) and the data contained therein without the written agreement of the legitimate data owners, as designated by Article 38(1) of the EU Regulation, is guilty of an offence.
(2) Paragraph (1) shall not apply in the case of access for the purpose of investigating potential incidents of falsification flagged in the system in accordance with Article 36(b) of the EU Regulation.
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paragraphs: A legal entity managing a repository used to verify the authenticity of or decommission the unique identifiers of medicinal products placed on the market in the State, as part of the repositories system, which refuses to grant the Authority access to that repository and the information contained therein for one of the purposes listed in Article 39 of the EU Regulation is guilty of an offence.
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paragraphs: (1) A person is not guilty of an offence under these Regulations where he or she distributes or supplies to the public a medicinal product that had been placed on the market without the safety features in the State before the coming into operation of these Regulations, provided the medicinal product is not repackaged or relabelled thereafter, until the expiry date of the medicinal product.
(2) Notwithstanding Regulation 17, until 31 December 2024 a wholesaler is not guilty of an offence for failure to verify the authenticity of and decommission the unique identifier of a medicinal product referred to in Article 22(a) of the EU Regulation where the medicinal product is manufactured and labelled for the United Kingdom market or for the United Kingdom market and the markets of Cyprus, Malta or the State, and which the wholesaler intends to distribute in the United Kingdom.