The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1999
These Regulations amend the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 (“the principal Regulations”). They provide that holders of wholesale dealer’s licences who import medicinal products for the purpose of sale and supply in specified circumstances where marketing authorisations are not required under The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I. 1994/3144) must meet specified requirements. These are equivalent to those imposed on people exempt from the requirement to hold a product licence by virtue of The Medicines (Exemption from Licences) (Importation) Order 1984 (S.I. 1984/673).