http://www.legislation.gov.uk/uksi/1997/322/contents/made

The Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997

Medicines

Legislation

King's Printer of Acts of Parliament

2016-08-31

MEDICINES

These Regulations, which come into force on 31st March 1997, implement the provisions of Council Directive 92/74/EEC widening the scope of Directive 81/851/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homeopathic veterinary medicinal products (OJ No. L297, 13.10.92, p. 12) insofar as they relate to homoeopathic veterinary medicinal products that satisfy all of the conditions specified in Article 7.1 of that Directive (“products”).

The Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997

Act

The Transfer of Functions (Medicines and Poisons) Order 1999

art.2(3)

The Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997

reg.2 defn(s).

The Transfer of Functions (Medicines and Poisons) Order 1999

art.5

Sch.

para.3

The Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997

Regulations

The Transfer of Functions (Medicines and Poisons) Order 1999

art. 2(3)

art. 3

art. 1(2)

The Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997

reg. 2(1)

The Transfer of Functions (Medicines and Poisons) Order 1999

Sch.

para. 3

art. 1(2)

The Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997

reg.37

Sch.6

The Medicines (Restrictions on the Administration of Veterinary Medicinal Products) Amendment Regulations 1997

reg.4

The Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997

reg.37

Sch.6

The Medicines (Restrictions on the Administration of Veterinary Medicinal Products) Amendment Regulations 1997

reg.4

The Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997

Regulations

The Veterinary Medicines Regulations 2005

Sch. 8

Pt. 1

Sch. 8

Pt. 4

reg. 1(a)

The Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997

PART IGENERAL

1Title and commencement

2Interpretation

3Homoeopathic veterinary medicinal products to which these Regulations apply

PART IIREGISTRATION OF PRODUCTS

4Applications for registration

5Examination of registration applications

6Registration of products

7Renewal of registrations

8Alteration of Article 8 dossiers relating to registered products

9Suspension and revocation of registrations

10Prohibition and withdrawal notices

11Procedure where the Ministers propose to take certain action on grounds relating to safety or quality

12Procedure where the Ministers propose to take certain action on grounds other than grounds relating to safety or quality

PART IIIARTICLE 24 AUTHORISATIONS

13Applications for Article 24 authorisations

14Issue of Article 24 authorisations

15Change of Article 25 particulars

16Suspension and revocation of Article 24 authorisations

17Procedure where the Ministers propose to refuse Article 24 authorisations or to suspend or revoke such authorisations

PART IVCONTROLS

18Restrictions on the marketing of products

19Duties on persons responsible for marketing registered products

20Prohibition on supply and withdrawal from the market

21Labelling and package inserts

22Restrictions on the manufacture of products

23Restrictions on imports of products from third countries

24Restrictions on exports of certain products to EEA States

25Duties on holders of Article 24 authorisations

26Duties on qualified persons

27Suspension of persons acting as qualified persons

PART VMISCELLANEOUS AND SUPPLEMENTAL PROVISIONS

28Confidentiality

29Issue of certificates

30Article 34 duties

31Enforcement

32Offence and penalties

33Defence

34Application of various sections of the Act

35Partial disapplication of various enactments

36Disapplication of various statutory instruments

37Amendment

SCHEDULE 1INTERPRETATION

PART IExpressions having the same meaning as in the Homoeopathics Directive

PART IIExpressions having the same meaning as in Directive 81/851

SCHEDULE 2PROCEDURE WHERE THE MINISTERS PROPOSE TO TAKE CERTAIN ACTION ON GROUNDS RELATING TO SAFETY OR QUALITY

1Subject to paragraph 8(1), where the Ministers propose to act...

2Where the Board is consulted pursuant to paragraph 1, the...

3After the Board has reported to the Ministers pursuant to...

4Where the Ministers provisionally determine to take the proposed regulation...

5(1) Where the Commission is consulted pursuant to paragraph 4,...

6Where the Commission is consulted pursuant to paragraph 4, the...

7After the Commission has reported to the Ministers pursuant to...

8(1) The provisions of paragraph 1 shall not apply where...

SCHEDULE 3PROCEDURE WHERE THE MINISTERS PROPOSE TO TAKE CERTAIN ACTION ON GROUNDS OTHER THAN GROUNDS RELATING TO SAFETY OR QUALITY

1(1) Where the Ministers propose to act in a manner...

SCHEDULE 4PROCEDURE WHERE THE MINISTERS PROPOSE TO REFUSE ARTICLE 24 AUTHORISATIONS OR TO SUSPEND OR REVOKE SUCH AUTHORISATIONS

1(1) Where the Ministers propose to act in a manner...

2Where a person on whom such notice is served under...

SCHEDULE 5APPLICATION OF VARIOUS SECTIONS OF THE ACT

SCHEDULE 6AMENDMENT

1997 No. 322

MEDICINES

The Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997

Made12th February 1997

Laid before Parliament18th February 1997

Coming into force31st March 1997

The Minister of Agriculture, Fisheries and Food and the Secretary of State, being Ministers designated1 for the purposes of section 2(2) of the European Communities Act 19722 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: