Explanatory note

These Regulations amend the Medicines (Manufacturer’s Undertakings for Imported Products) Regulations 1977 (“the 1977 Regulations”) so implementing in part Commission Directive 91/356/EEC (OJ No. L193, 17.7.91, p.30) (“the Directive”) so as to prescribe additional conditions to the undertakings given by or on behalf of manufacturers of imported medicinal products in connection with an application for the grant of a product licence.

In particular, these Regulations require manufacturers to undertake—

• to provide and maintain an independent quality control department (regulation 6(2), article 11(1) of the Directive);

• to maintain an effective pharmaceutical quality assurance system (regulation 6(3), article 6 of the Directive);

• to require the keeping of records for five years or until one year after the expiry date of the product (regulation 6(4), article 9 of the Directive);

• to retain samples of starting materials and finished products for the periods prescribed and to keep appropriate records (regulation 6(5), article 11(4) of the Directive); and

• to maintain an effective system whereby complaints are reviewed (regulation 6(5), article 13 of the Directive).

These Regulations also exclude from the scope of the 1977 Regulations applications relating to products imported from another member State of the European Economic Community (regulations 4 and 5).