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The Medicines (Products for Human Use) (Fees) Regulations 2012

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This is the original version (as it was originally made).

Variation of parallel import licence

This section has no associated Explanatory Memorandum

39.—(1) The fee payable under regulation 18(1) in connection with an application for variation of a parallel import licence is—

(a)£13,595 if, were the marketing authorization not a parallel import licence, the application for the variation would be a reclassification variation application falling within paragraph 15(a) and to which paragraph 37 of this Schedule does not apply;

(b)£9,252 if, were the marketing authorization not a parallel import licence, the application for the variation would be a reclassification variation application falling within paragraph 15(b) and to which paragraph 37 of this Schedule does not apply; and

(c)£386, in any other case other than where the variation applied for is an administrative variation.

(2) For the purposes of sub-paragraph (1)(c) an application for an administrative variation is where the variation applied for falls within one of the following paragraphs—

(a)a change of either or both of the name and the address of the holder of the licence;

(b)a change of either or both of the name and the address of a manufacturer, assembler, storer or distributor named in the licence where the change has been occasioned by the taking over of an existing business, whether by purchase, merger or otherwise, and any change of address does not involve a change of the site of manufacture, assembly or storage or of the site from which distribution takes place;

(c)the removal from the licence of details of one or more of the sites of manufacture, assembly or storage or of the sites from which distribution takes place;

(d)the removal from the licence of details of any of the activities to which the licence relates;

(e)the removal from the licence of details of any of the medicinal products which the holder of the licence is authorized to import;

(f)the addition or deletion of the name and address of the suppliers of the medicinal product to which the licence relates, or a change in the name, the address, or both the name and address, of the suppliers of that product; or

(g)unless paragraph 8 of Schedule 6 applies, a change consequential upon any or any combination of the following—

(i)a change of ownership of the United Kingdom marketing authorization in respect of which the parallel import licence was granted,

(ii)a change to the number of the United Kingdom marketing authorization in respect of which the parallel import licence was granted,

(iii)a change to the name of the holder of the United Kingdom marketing authorization in respect of which the parallel import licence was granted,

(iv)a change to the address of the holder of the United Kingdom marketing authorization in respect of which the parallel import licence was granted,

(v)a change to the number of the marketing authorization for the product in the country where the product originates,

(vi)a change of ownership of the marketing authorization for the product in the country where the product originates,

(vii)a change to the name of the holder of the marketing authorization for the product in the country where the product originates, or

(viii)a change to the address of the holder of the marketing authorization for the product in the country where the product originates,

where the change has been occasioned by the taking over of an existing business, whether by purchase, merger or otherwise, if the marketing authorization was not a parallel import licence, the application for that variation would be a reclassification variation application to which paragraph 38 of this Schedule applies.

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