http://www.legislation.gov.uk/uksi/1977/1038/note/made
The Medicines (Manufacturer's Undertakings for Imported Products) Regulations 1977
Westlaw
King's Printer of Acts of Parliament
2011-05-19
MEDICINES
These Regulations made under section 19(3)(b) of the Medicines Act 1968 prescribe the conditions which are to be incorporated in undertakings given by or on behalf of overseas manufacturers of imported medicinal products where applicants are required by the licensing authority to produce the undertakings in connection with applications for product licences. The regulations relate to such matters as the provision of staff, premises and plant for the manufacture, handling and storage of medicinal products, record keeping and the supply of information to holders of product licences.
The Medicines (Manufacturer's Undertakings for Imported Products) Regulations 1977
reg.2(1A)
The Medicines (Manufacturer’s Undertakings for Imported Products) Amendment Regulations 1992
reg.3
The Medicines (Manufacturer's Undertakings for Imported Products) Regulations 1977
reg.3
The Medicines (Manufacturer’s Undertakings for Imported Products) Amendment Regulations 1992
reg.4
The Medicines (Manufacturer's Undertakings for Imported Products) Regulations 1977
reg.4
The Medicines (Manufacturer’s Undertakings for Imported Products) Amendment Regulations 1992
reg.5
The Medicines (Manufacturer's Undertakings for Imported Products) Regulations 1977
Sch
paras 2A
3A
The Medicines (Manufacturer’s Undertakings for Imported Products) Amendment Regulations 1992
reg.6(2)
(3)
The Medicines (Manufacturer's Undertakings for Imported Products) Regulations 1977
Sch
para 7(a)(b)
The Medicines (Manufacturer’s Undertakings for Imported Products) Amendment Regulations 1992
reg.6(4)
The Medicines (Manufacturer's Undertakings for Imported Products) Regulations 1977
Sch
paras 7A
7B
The Medicines (Manufacturer’s Undertakings for Imported Products) Amendment Regulations 1992
reg.6(5)
The Medicines (Manufacturer's Undertakings for Imported Products) Regulations 1977
reg. 1A
The Veterinary Medicines Regulations 2005
Sch. 8 Pt. 3
para 11
Sch. 8
Pt. 4
reg. 1(a)
The Medicines (Manufacturer's Undertakings for Imported Products) Regulations 1977
reg. 2(1)
The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994
Sch. 7
para. 4
reg. 1(1)
EXPLANATORY NOTE
These Regulations made under section 19(3)(b) of the Medicines Act 1968 prescribe the conditions which are to be incorporated in undertakings given by or on behalf of overseas manufacturers of imported medicinal products where applicants are required by the licensing authority to produce the undertakings in connection with applications for product licences. The regulations relate to such matters as the provision of staff, premises and plant for the manufacture, handling and storage of medicinal products, record keeping and the supply of information to holders of product licences.