The Medicines (Manufacturer’s Undertakings for Imported Products) Amendment Regulations 1992
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.