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Regulation 2 Interpretation

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

  • reg.2(1) (defns of generator, kit, precursor and product to which Chs II to V of the 1965 Directive applies) added by Medicines (Leaflets) 1992 reg.2(2)
  • reg.2(1) (defn of proprietary medicinal product) substituted by Medicines (Leaflets) 1992 reg.2(3)
  • reg.2(01) (defns of radiopharmaceutical , radiopharmaceutical -associated product, relevant medicinal product and summary of product characteristics) added by Medicines (Leaflets) 1992 reg.2(4)
  • reg.2(1) (defns of certificate of registration, homoeopathic medicinal product and homoeopathic product, which Council directive 92/73/EEC appl) added by Medicines (Labelling and Leaflets) 1994 reg.5(2)(3)
  • reg.2(1) (defns of product, which Chapters II to V of the 1965 Directive apply and proprietary medicinal product) amended by Medicines (Labelling and Leaflets) 1994 reg.5(4)(5)
(1)

In these regulations, unless the context otherwise requires—

  • “the Act” means the Medicines Act 1968;

  • “medicinal product” has the same meaning as in section 130(1)(a) of the Act;

  • “proprietary medicinal product” means—

    1. (a)

      a ready-prepared medicinal product placed on the market in the United Kingdom under a special name and in a special pack,

    2. (b)

      for the purposes of paragraph (a) “medicinal product” does not include—

      1. (i)

        vaccines, toxins or serums,

      2. (ii)

        medicinal products based on human blood or blood constituents or radioactive isotopes,

      3. (iii)

        homoeopathic medicinal products, or

      4. (iv)

        veterinary drugs;

and other expressions have the same meanings as in the Act or in the Medicines (Labelling) Regulations 1976f1 as amendedf2

(2)

Except in so far as the context otherwise requires, any reference in these regulations to any enactment, order or regulations shall be construed as a reference to that enactment or order or those regulations, as the case may be, as amended, extended or re-enacted by any other enactment, order or regulations.

(3)

The rules for the construction of Acts of Parliament contained in the Interpretation Act 1889 shall apply for the purposes of the interpretation of these regulations as they apply for the purposes of the interpretation of an Act of Parliament.

Annotations

Footnotes

f1

(1976 III, p. 4570).

f2

S.I. 1977/996 (1977 II, p. 2813).