Medicines Standard Provisions for Licences and

The Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 (1971 No. 972), as amended. London HMSO, 1971. 

Regulations. There were no provisions in the 1994 Regulations to parallel the 1984 Order and consequently the controls on imported unlicensed products were reduced to the level of those on products manufactured in the United Kingdom. This was clearly the result of an oversight and additional controls were reinstated in February 1999 by the Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1999. ... 

The regulations introduce a number of amendments into Schedule 3 (standard provisions for wholesale dealer s licences) of the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971. The 1999 Regulations reproduce the relevant wording from the Directive (including the reference to special needs ). Supply of an exempt imported product falling within the scope of this wording is only permitted provided certain conditions are complied with ... 

The standcird provisions attaching to CTCs are given in SI 1971 No. 972 The Medicines (Standard Provisions for Licences and Certificates) Regulations and any subsequent amendments (including SI 1972/1226,1974/1523, 1977/675,1977/1039, 1977/1053,1983/1730,1992/2846,1993/833,1994/103). The MCA provides guidance notes on applications for cliniccil trial exemptions cind clinical trial certificates. Special forms (MLA 202, 232, md 221) obtainable from the MCA are provided for use by applicants in preparing a CTC application, variation, and renewal. 

By its existence, the Medicines Act recognises the right of the pharmaceutical industry to advertise and promote its products, and by the standard provisions for product licences it is possible to control product... 

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