Regulation 29 Variation of licence on the application of the holder

(1)

This regulation applies if the holder of a licence under this Part applies to the licensing authority for a variation of the licence.

(2)

The application must—

(a)

be in writing;

(b)

specify the variation requested;

(c)

be signed by or on behalf of the applicant;

(d)

be accompanied by such information as may be required to enable the licensing authority to consider the application; and

(e)

be accompanied by the required fee (if any).

F1(2A)

In the case of an application of a type specified in paragraph (2C), the information to be provided under paragraph (2)(d) must include the information specified in paragraph 1A(2) of Schedule 3.

(2B)

In the case of an application of a type specified in paragraph (2D), the information to be provided under paragraph (2)(d) must include the information specified in paragraph 1B(2) of Schedule 3.

(2C)

The following types of application are specified for the purpose of paragraph (2A) and (2E)—

(a)

an application to vary the licence so that it relates to the manufacture or assembly of MM medicinal products;

(b)

an application to vary a manufacturer’s licence (MM) to add a new MM medicinal product.

(2D)

The following types of application are specified for the purpose of paragraphs (2B) and (2F)—

(a)

an application to vary the licence so that it relates to the manufacture or assembly of POC medicinal products;

(b)

an application to vary a manufacturer’s licence (POC) to add a new POC medicinal product.

(2E)

In dealing with an application of a type specified in paragraph (2C), the licensing authority must take into consideration the arrangements made or to be made for—

(a)

supervising and controlling operations at a modular unit specified in the application; and

(b)

ensuring that manufacture or assembly is under appropriate control so that the MM medicinal product consistently satisfies the requirements in the MM master file when manufactured at that modular unit.

(2F)

In dealing with an application of a type specified in paragraph (2D), the licensing authority must take into consideration the arrangements made or to be made for—

(a)

supervising and controlling operations at a POC site specified in the application; and

(b)

ensuring that manufacturing or assembly is under appropriate control so that the POC medicinal product consistently satisfies the requirements in the POC master file when manufactured at that POC site.

(3)

The licensing authority must consider an application made in accordance with this regulation.

(4)

If paragraph (5) applies, the licensing authority must vary the licence or refuse to vary it before the end of the period allowed for considering the application.

(5)

This paragraph applies to a variation which would have the effect of altering—

(a)

the types of medicinal product in respect of which the licence was granted;

(b)

any operation carried out under the licence; F2...

(c)

any premises, equipment or facilities in respect of which the licence was F3granted; or

F4(d)

the responsible person (import) under regulation 45AA.

(6)

The period allowed for consideration of an application under this regulation is—

(a)

in a case where the licensing authority considers that it is necessary to inspect premises to which the licence relates, 90 days beginning with the day after the date when the licensing authority receives the application; and

(b)

in any other case 30 days beginning with that day.

(7)

The licensing authority may give a notice to the applicant requiring the applicant to supply further information in connection with the application.

(8)

If a notice under paragraph (7) requires the applicant to provide the licensing authority with information, the information period is not to be counted for the purposes of paragraph (6).

(9)

In paragraph (8), the “information period” means the period—

(a)

beginning with the day on which the notice is given; and

(b)

ending with the day on which the licensing authority receives the information or the applicant shows to the licensing authority's satisfaction that the applicant is unable to provide it.

(10)

Nothing in this regulation affects the powers conferred by regulation 26.