Regulation 5 Amendment of Part III of Schedule 1 to the principal Regulations
In paragraph 2 of Part III of Schedule 1 to the principal Regulations (variations of manufacturers' licences), for the words “paragraph 4” there shall be substituted the words “paragraphs 4A and 5”.
In paragraph 3 of Part III of Schedule 1 to the principal Regulations (variations of wholesale dealers' licences), for the words “paragraph 4” there shall be substituted the words “paragraphs 4B and 5”.
For paragraph 4 of Part III of Schedule 1 to the principal Regulations (fees for applications for variations of licences) there shall be substituted the following—
“Other variations to Product Licences
4The fee payable under regulation 6(a) of these Regulations in connection with an application for variation of a product licence shall be £100 in respect of each variation applied for which 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 from which distribution takes place;
(c)the removal from the licence of details of one or more sites of manufacture, assembly or storage or 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 indications authorised for administration of the medicinal product;
(f)in relation to a product licence (parallel import), the removal from the licence of details of any of the medicinal products which the holder of the licence is authorised to import.
Other variations to Manufacturers' Licences
4AThe fee payable under regulation 6(a) of these Regulations in connection with an application for variation of a manufacturer’s licence shall be £100 in respect of each variation applied for which 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 where any change of address does not involve a change of the site of manufacture, assembly or storage or from which distribution takes place;
(b)a change of either or both of the name and the address of an 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 from which distribution takes place;
(c)the removal from the licence of details of one or more sites of manufacture, assembly or storage or from which distribution takes place;
(d)the removal from the licence of details of one or more persons named as a qualified person, as the person to be in charge of quality control or as the production manager;
(e)the removal from the licence of details of a medicinal product or range of medicinal products which the holder of the licence is authorised to manufacture;
(f)the removal from the licence of details of one or more manufacturing or assembly operations specified in the licence as an operation which the holder of the licence is authorised to carry out.
Other variations to Wholesale Dealers' Licences
4BThe fee payable under regulation 6(a) of these Regulations in connection with an application for variation of a wholesale dealer’s licence shall be £100 in respect of each variation applied for which 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 where any change of address does not involve a change of the site of wholesale dealing or storage or from which distribution takes place;
(b)a change of either or both of the name and the address of a 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 wholesale dealing or storage or from which distribution takes place;
(c)the removal from the licence of details of one or more sites of wholesale dealing or storage or from which distribution takes place;
(d)the removal from the licence of details of one or more persons named as a qualified person;
(e)the removal from the licence of details of any medicinal product or range of medicinal products which the holder of the licence is authorised to sell or offer for sale by way of wholesale dealing.”.