Search Legislation

The Medicines (Medicines Act 1968 Amendment) Regulations 1983

What Version

 Help about what version
  • Latest available (Revised)
  • Original (As made)

Opening Options

 Help about opening options

Status:

This is the original version (as it was originally made). This item of legislation is currently only available in its original format. The electronic version of this UK Statutory Instrument has been contributed by Westlaw and is taken from the printed publication. Read more

Statutory Instruments

1983 No. 1724

MEDICINES

The Medicines (Medicines Act 1968 Amendment) Regulations 1983

Made

21st November 1983

Laid before Parliament

30th November 1983

Coming into Operation

21st December 1983

The Secretary of State and the Minister of Agriculture, Fisheries and Food being Ministers designated(1) for the purposes of section 2(2) of the European Communities Act 1972 in relation to medicinal products, acting jointly, in exercise of the powers conferred on them by the said section 2(2), hereby make the following regulations:—

Title, commencement and interpretation

1.—(1) These regulations may be cited as the Medicines (Medicines Act 1968 Amendment) Regulations 1983 and shall come into operation on 21st December 1983.

(2) In these regulations “the Act” means the Medicines Act 1968.

Amendment of section 7 of the Act

2.—(1) Section 7 of the Act (general provisions as to dealing with medicinal products)(2) shall be amended as follows.

(2) For subsection (5)(b) there shall be substituted—

(b)if that product is a proprietary medicinal product or a ready-made veterinary drug, is responsible for the placing of the product on the market in the United Kingdom.

(3) For subsection (7) there shall be substituted—

(7) In subsection (5) of this section—

(a)proprietary medicinal product” means a ready-prepared medicinal product placed on the market in the United Kingdom under a special name and in a special pack; and for the purposes of this definition “medicinal productdoes not include—

(i)vaccines, toxins or serums,

(ii)medicinal products based on human blood or blood constituents or radioactive isotopes,

(iii)homoeopathic medicinal products, or

(iv)additives for animal feeding stuffs to which the provisions of Council Directive 70/524/EEC apply;

(b)ready-made veterinary drug” means a ready-prepared veterinary drug placed on the market in the United Kingdom in a pharmaceutical form in which it may be used without further processing, not being a drug placed on the market under a special name and in a special pack; and for the purposes of this definition “veterinary drugdoes not include—

(i)vaccines, toxins or serums,

(ii)veterinary drugs based on radioactive isotopes,

(iii)veterinary drugs specially prepared for administration by a veterinary surgeon or veterinary practitioner to a particular animal or herd which is under his care,

(iv)homoeopathic veterinary drugs, or

(v)additives for animal feeding stuffs to which the provisions of Council Directive 70/524/EEC apply.

Amendment of section 8 of the Act

3.—(1) Section 8 of the Act (provisions as to manufacture and wholesale dealing)(3) shall be amended as follows.

(2) In subsection (3)(b), after the words “proprietary medicinal product” there shall be inserted the words “or ready-made veterinary drug.”

(3) For subsection (4) there shall be substituted—

(4) Subsection (7) of section 7 of this Act shall apply for the purposes of subsection (3) of this section as it applies for the purposes of subsection (5) of that section.

Amendment of section 18 of the Act

4.  For subsection (3) of section 18 of the Act (applications for licences)(4) there shall be substituted—

(3) Where documents that constitute a dossier for the purposes of Article 9 of the Second Council Directive 75/319/EEC of 20 May 1975 are forwarded to the licensing authority under and in accordance with the said Article, or documents are forwarded to that authority under and in accordance with Article 17 of Council Directive 81/851/EEC of 28 September 1981, such forwarding shall be deemed to be an application for the grant of a product licence under this Part of this Act.

Norman Fowler

Secretary of State for Social Services

21st November 1983

In Witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 26th October 1983.

L.S.

Michael Jopling

Minister of Agriculture, Fisheries and Food

EXPLANATORY NOTE

These Regulations amend the Medicines Act 1968 (“the Act”) thereby implementing in part Council Directive 81/851/EEC, on the approximation of the laws of the Member States relating to veterinary medicinal products.

The Regulations—

(1) amend sections 7 and 8 of the Act so as to require persons responsible for placing on the market in the United Kingdom veterinary drugs which are proprietary medicinal products or ready-made veterinary drugs to hold licences and also to require distributors of such drugs imported from outside the European Communities to hold licences (Regulations 2 and 3); and

(2) amend section 18 of the Act so as to provide that documents forwarded to the licensing authority under Article 17 of Council Directive 81/851/EEC shall be treated as an application for the grant of a product licence under the Act (Regulation 4).

(1)

S.I. 1972/1811.

(2)

Section 7 was amended by S.I. 1977/1050 and S.R. (N.I.) 1977 No. 170.

(3)

Section 8 was amended by S.I. 1977/1050 and S.R. (N.I.) 1977 No. 170.

(4)

Section 18 was amended by S.I. 1977/1050 and S.R. (N.I.) 1977 No. 170.

Back to top

Options/Help

Print Options

Close

Legislation is available in different versions:

Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.

Original (As Enacted or Made):The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.

Close

Opening Options

Different options to open legislation in order to view more content on screen at once

Close

More Resources

Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as enacted version that was used for the print copy
  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • correction slips
  • links to related legislation and further information resources
Close

More Resources

Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as made version that was used for the print copy
  • correction slips

Click 'View More' or select 'More Resources' tab for additional information including:

  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • links to related legislation and further information resources