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Paragraph 1 Marketing authorizations

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

In this Part of this Schedule—

  • “Type I Application” means an application by a marketing authorisation holder to vary a marketing authorization (not being a marketing authorization (parallel import)) which is a “minor variation” within the meaning of Article 3.1(a) of Regulation (EC) No. 541/95f1;

  • “Type II Application” means any application to vary a marketing authorization (not being a marketing authorization (parallel import) or a product licence of right) which is neither a Type I Application nor an application for a Type II complex variation nor a change to which Annex II to Commission Regulation (EC) 541/95 applies;

  • “Type II complex variation” means a variation of a marketing authorization which relates to a change—

    1. (a)

      in the formulation of a medicinal product comprising one or more of the following

      1. (i)

        a change which necessitates in-vivo bioavailability studies to be performed on that product:

      2. (ii)

        a change in that product’s preservative system; or

      3. (iii)

        a change in that product’s excipients which significantly affects the pharmaceutical or the therapeutic properties of that product; or

    2. (b)

      in the therapeutic indications of a medicinal product, such as a change in respect of use in a new category of patients or as a treatment for a new category of disease, other than a change to which paragraph 2 (changes to therapeutic indications) of Annex II to Commission Regulation (EC) No. 541/95 applies;

    3. (c)

      in the composition, manufacture or use of a medicinal product to which any one or more of paragraphs (c), (e), (g) to (j) or (n) of the definition of complex application would apply where an application for a marketing authorisation is made in respect of a medicinal product.

Annotations

Footnotes

f1

OJ No. L55, 11.3.95,p. 7.