Regulation 3 Additional regulations

The principal regulations shall be amended by adding after Regulation 3 the following regulations:—

““Standard provisions for manufacturer's licences and manufacturer's licences of right for vaccines, toxins and sera

4

(1)

In addition to the standard provisions for manufacturer's licences set out in Schedule 2 to these regulations, the standard provisions for manufacturer's licences, including manufacturer's licences of right, relating to vaccines for human use shall be the following—

(a)

for all vaccines, including smallpox vaccine and BCG vaccine, those provisions set out in Part I of Schedule 4 to these regulations,

(b)

for smallpox vaccine, those provisions set out in Part II of Schedule 4 to these regulations, and

(c)

for BCG vaccine, those provisions set out in Part III of Schedule 4 to these regulations.

(2)

In addition to the standard provisions for manufacturer's licences set out in Schedule 2 to these regulations, the standard provisions for manufacturer's licences, including manufacturer's licences of right, relating to toxins and sera for human use shall be the following—

(a)

for toxins, those provisions set out in Part IV of Schedule 4 to these regulations, and

(b)

for sera, those provisions set out in Part V of Schedule 4 to these regulations.

Standard provisions for product licences including product licences of right for certain medicinal products

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(1)

In addition to the standard provisions for product licences set out in Part I of Schedule 1 to these regulations, the standard provisions for product licences, including product licences of right, relating to medicinal products to which this regulation applies shall be those provisions set out in Schedule 5 to these regulations.

(2)

The standard provisions contained in this regulation shall only apply to medicinal products which include a substance or substances specified in paragraphs 1 to 35 in column 1 of Schedule 1 to the Medicines (Control of Substances for Manufacture) Order 1971^f1 in the circumstances set out in column 2 of the said Schedule other than medicinal products as aforesaid manufactured, assembled, sold, supplied, imported or exported for use as veterinary drugs.”.