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Veterinary Medicines Regulations 2013

Veterinary Medicines Regulations 2013

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Published by Fuzzy_Wood_Person
British Statutory Instrument concerning Veterinary medicines
British Statutory Instrument concerning Veterinary medicines

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Published by: Fuzzy_Wood_Person on Aug 22, 2013
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12/30/2013

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STATUTORY INSTRUMENTS
2013 No. 2033MEDICINES
The Veterinary Medicines Regulations 2013
 Made
 
-
 
-
 
-
 
-
 
6th August 2013 Laid before Parliament 
 
20th August 2013Coming into force
 
-
 
-
 
1st October 2013
CONTENTS
PART 1
Introduction
1. Title and commencement 42. Definition of “veterinary medicinal product”, interpretation and scope 43. Products to which these Regulations do not apply 5
PART 2
Authorised veterinary medicinal products
4. Placing a veterinary medicinal product on the market 55. Manufacture of veterinary medicinal products 66. Marketing of products not in accordance with a marketing authorisation 67. Classification, supply and possession of the product 68. Administration of the product 69. Importation of authorised veterinary medicinal products 610. Advertising the product 711. Advertising of prescription products and products containing psychotropic drugs ornarcotics 712. Defence of publication in the course of business 813. Wholesale dealing 814. Feedingstuffs 815. Exemptions 816. Fees 8
PART 3
Records
17. Food-producing animals: proof of purchase of veterinary medicinal products 918. Food-producing animals: records of administration by a veterinary surgeon 9
 
219. Food-producing animals: records of acquisition and administration 920. Food-producing animals: retention of records 921. Records by a holder of a manufacturing authorisation 1022. Records by a holder of a wholesale dealer’s authorisation 1023. Records of the receipt or supply of prescription products 1024. Records of products administered to a food-producing animal under the cascade 11
PART 4
Unauthorised veterinary medicinal products
25. Importation of an unauthorised veterinary medicinal product 1126. Possession of an unauthorised veterinary medicinal product 1227. Supply of an unauthorised veterinary medicinal product 12
PART 5
Miscellaneous provisions, enforcement and offences
28. The Veterinary Products Committee 1229. Veterinary Products Committee appeals procedure 1330. Appeals to an appointed person 1331. Exports 1432. Time limits 1433. Appointment of inspectors 1434. Powers of entry 1435. Powers of an inspector 1536. Inspection of pharmacies 1637. Obstruction 1638. Improvement notices 1639. Appeals against improvement notices 1740. Powers of a court on appeal 1741. Seizure notices 1742. Publication 1843. Offence 1844. Penalties 1845. Northern Ireland 1946. Review 2047. Revocations 21SCHEDULE 1 Marketing authorisations 21PART 1 Application for a marketing authorisation 24PART 2 Derogations from some of the requirements in Part 1 27PART 3 Grant of a marketing authorisation 29PART 4 Variations of marketing authorisations on the application of theholder 33PART 5 Suspension, etc. of a marketing authorisation 34PART 6 Mutual recognition and multiple applications 35PART 7 Labelling and package leaflets 37
 
3PART 8 Pharmacovigilance 40PART 9 Homeopathic remedies 43SCHEDULE 2 The manufacture of veterinary medicinal products 45PART 1 Manufacturing authorisations 46PART 2 Authorisation of manufacturers of autogenous vaccines 50PART 3 Authorisation of blood banks 51PART 4 Authorisation of manufacturers of products for administrationunder the cascade 52PART 5 Authorisation of equine stem cell centres 53SCHEDULE 3 Classification and supply, wholesale dealers and sheep dip 55PART 1 Classification and supply of authorised veterinary medicinalproducts 56PART 2 Requirements for a wholesale dealer’s authorisation 63PART 3 Sheep dip 64SCHEDULE 4 Administration of a veterinary medicinal product outside theterms of a marketing authorisation 65SCHEDULE 5 Medicated feedingstuffs and specified feed additives 69SCHEDULE 6 Exemptions for small pet animals 80SCHEDULE 7 Fees 82PART 1 Introduction 84PART 2 Fees relating to marketing authorisations 85PART 3 Fees payable by manufacturers 101PART 4 Fees relating to a wholesale dealer’s authorisation 103PART 5 Fees relating to feedingstuffs 105PART 6 General 108The Secretary of State is a Minister designated(
a
) for the purposes of making Regulations undersection 2(2) of the European Communities Act 1972(
b
) in relation to measures in the veterinaryand phytosanitary fields for the protection of public health.The Secretary of State has carried out the consultation required by Article 9 of Regulation (EC)No 178/2002 of the European Parliament and of the Council laying down the general principlesand requirements of food law, establishing the European Food Safety Authority and laying downprocedures in matters of food safety(
c
).In accordance with section 56(1) of the Finance Act 1973(
d
), the Treasury consent to the makingof these Regulations.The Secretary of State makes these Regulations in exercise of the powers conferred by section2(2) of the European Communities Act 1972 and by section 56(1) of the Finance Act 1973.
(
a
) S.I. 1999/2027.(
b
) 1972 c. 68.(
c
) OJ No L31, 1.2.2002, p. 1.(
d
) 1973 c. 51.

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