Citation and commencement1.
These regulations may be cited as the Medicines (Manufacturer's Undertakings for Imported Products) Regulations 1977 and shall come into operation on 14th July 1977.
Interpretation2.
(1)
In these regulations, unless the context otherwise requires, “medicinal product” includes, where a product licence relates to any substance or article which is not a medicinal product, the substance or article to which the licence relates or is intended to relate, and other expressions have the same meanings as in the Medicines Act 1968.
(2)
Except in so far as the context otherwise requires, any reference in these regulations to any enactment shall be construed as a reference to that enactment as amended, extended or re-enacted by any other enactment or by any order or regulations.
(3)
The rules for the construction of Acts of Parliament contained in the Interpretation Act 1889 shall apply for the purposes of the interpretation of these regulations as they apply for the purposes of the interpretation of an Act of Parliament.
Prescribed conditions for manufacturer's undertakings3.
The prescribed conditions for the purposes of undertakings in accordance with section 19(3)(b) of the Medicines Act 1968 given by, or on behalf of, manufacturers of medicinal products which have been or are to be imported shall be those conditions set out in the Schedule to these regulations.
In witness whereof the official seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 10th June 1977.
Sealed with the official seal of the Department of Health and Social Services for Northern Ireland this 15th day of June 1977.
Sealed with the official seal of the Department of Agriculture for Northern Ireland this 16th day of June 1977.