The Human Medicines Regulations 2012

Findings and reports of inspections

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 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) 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;

(b) the guidelines on good distribution practice referred to in Article 84 of the 2001 Directive; and

(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.

(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.