PART 16U.K.Enforcement

Findings and reports of inspectionsU.K.

331.—(1) If the outcome of the inspection of things referred to in regulation 327(2)(g) (powers of inspection, sampling and seizure: information and documents relating to safety etc) is that the holder of a [F1UK marketing authorisation, EU marketing authorisation] or traditional herbal registration does not comply with the pharmacovigilance system as described in the pharmacovigilance system master file, or any provision of Part 11 (pharmacovigilance), the enforcement authority must—

(a)bring the deficiencies to the attention of the holder;

(b)give the holder the opportunity to submit comments; and

(c)[F2in the case of a product authorised under a UKMA(NI) or UKMA(UK),] inform the other EEA States, the EMA and the European Commission.

(2) Paragraph (1) is without prejudice to paragraphs (3) and (5).

(3) After every inspection carried out in accordance with regulations 325 (rights of entry) and 327 (powers of inspection, sampling and seizure) in connection with medicinal products other than registrable homoeopathic medicinal products, the enforcement authority must report on whether the activities to which the inspection relates comply with such of the provisions mentioned in paragraph (4) as apply to those activities.

(4) Those provisions are—

(a)the Good Manufacturing Practice Directive and any principles or guidelines of good manufacturing practice referred to in Article 47 of the 2001 Directive;

[F3(b)the guidelines on good distribution practice—

(i)in the case of Great Britain, published under, or that apply by virtue of, regulation C17;

(ii)in the case of Northern Ireland, published by the European Commission in accordance with Article 84 of the 2001 Directive;]

(c)in the case of the holder of a marketing authorisation or traditional herbal registration—

(i)Part 11 (pharmacovigilance), and

(ii)Chapter 3 (pharmacovigilance) of Title II (authorisation and supervision of medicinal products for human use) of Regulation (EC) No 726/2004.

[F4(d)Schedule 12A; and

(e)the Implementing Regulation (as defined in regulation 177(5)).]

(5) The enforcement authority must before adopting the report —

(a)communicate the content of the report to the person to whose activities the inspection relates; and

(b)give that person the opportunity to submit comments.

Textual Amendments