Regulation on the establishment of expert committees for standard authorisations, pharmacy and prescription of medicinal products (Medicinal Products Expert Regulation-AMSachvV)

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AMSachvV

Date of completion: 02.01.1978

Full quote:

" Medicinal Products Expert Regulation of 2 January 1978 (BGBl. 30), as last amended by Article 53 of the Regulation of 31 August 2015 (BGBl I). I p. 1474).

Status:

Last amended by Art. 53 V v. 31.8.2015 I 1474

For more details, please refer to the menu under Notes

Footnote

(+ + + Text proof applicable: 18.2.1983 + + +) 

  

Heading: abbreviated name and abbreviation by Art. 1 No. 1 G v. 10.4.2013 I 811 mWv 20.4.2013 Unofficial table of contents

Input formula

On the basis of § 53 of the Medicines Act of 24 August 1976 (BGBl. I p. 2445, 2448) is prescribed: Unofficial table of contents

§ 1

The Federal Ministry of Health (Federal Ministry of Health) hears before the adoption of a legal regulation

1.

In accordance with Article 36 (1) of the Medicines Act, an expert committee for standard authorisations,

2.

Pursuant to Section 45 (1) and § 46 (1) of the Medicinal Products Act, an expert committee for pharmacy duty and

3.

Pursuant to Section 48 (2) of the Medicinal Products Act, an expert committee for prescription-only

. In the case of medicinal products intended for use in animals, the Federal Ministry of Food and Agriculture shall be replaced by the Federal Ministry for Food and Agriculture in the cases set out in the first sentence of 1 (2) and (3). Unofficial table of contents

§ 2

(1) The Standard Authorisation Committee shall be responsible for:

1.

three university lecturers of pharmacology, of which a professor of veterinary medicine is a professor,

2.

two university lecturers of pharmacy,

3.

a representative of the German Hospital Society,

4.

a representative of the hospital pharmacist,

5.

A representative of the Drug Commission of the German Medical Association,

6.

a general practitioner,

7.

a dentist,

8.

a veterinarian,

9.

a medical practitioner,

10.

three representatives of the pharmaceutical industry, of which a representative of the veterinary pharmaceutical industry,

11.

a representative of the pharmacy,

12.

a representative of the reform goods manufacturers,

13.

a representative of the retail trade outside the pharmacies;

14.

a representative of the consumer's working group,

15.

a representative of the trade unions and

16.

two representatives of the social security institutions.

(2) The Committee on Pharmacy is required to:

1.

three university lecturers of medicine, of which each is a professor of pharmacology, internal medicine and veterinary medicine,

2.

a university lecturer in pharmacy,

3.

a representative of the German Hospital Society,

4.

a general practitioner,

5.

a dentist,

6.

a veterinarian,

7.

a medical practitioner,

8.

two representatives of the humanpharmaceutical industry,

9.

two representatives of the veterinary pharmaceutical industry,

10.

a representative of the reform goods manufacturers,

11.

two representatives of the pharmacy,

12.

two representatives of the retail trade outside the pharmacies,

13.

a representative of the consumer's working group; and

14.

two representatives of the social security institutions.

(3) The Committee on Prescription Duty shall be members of the

1.

as voting members

a)

two university lecturers of pharmacology, one of which is a professor of veterinary medicine, and a professor of clinical pharmacology,

b)

two university lecturers of pharmacy, of which a university lecturer in the subject of clinical pharmacy,

c)

two university lecturers of Internal Medicine, of which a university lecturer in veterinary medicine,

d)

a university lecturer in the field of general medicine,

e)

a university lecturer in the field of child and adolescent medicine,

f)

a university lecturer in medical statistics or epidemiology,

g)

a member of the Drug Commission of the German Medical Association,

h)

a member of the veterinary medicinal commission of veterinarians and

i)

a member of the Pharmacists ' Commission of the German Pharmacists and

2.

as non-voting members

a)

a specialist in general medicine,

b)

a specialist in internal medicine,

c)

a specialist in pediatric and adolescent medicine,

d)

a dentist,

e)

a veterinarian,

f)

a medical practitioner,

g)

a representative of the pharmacy,

h)

two representatives of the humanpharmaceutical industry and

i)

a representative of the veterinary pharmaceutical industry.

(4) Each member of the committees shall have a deputy. Unofficial table of contents

§ 3

(1) The members of the committees and their alternates shall be appointed by the Federal Ministry in agreement with the Federal Ministry of Food and Agriculture for a uniform period of five years each. Successors for prematurely departing members or deputiors shall be appointed only for the rest of the respective appeal period. (2) Repeated vocations shall be admissible. (3) Members and deputists may be allowed to do so by written declaration. (4) The activity of the committees is carried out on a voluntary basis. Unofficial table of contents

§ 4

The members of the committees and their alternates shall, even after the termination of their honorary activity, maintain secrecy on the matters which have become known to them. This shall not apply to communications concerning facts which are obvious or which do not require secrecy in their importance. Unofficial table of contents

§ 5

(1) The committees are under the chairmanship of the President of the Federal Institute for Drugs and Medical Devices. The meetings are not open to the public. (2) The committees are run by the Federal Institute for Medicinal Products and Medical Devices. (3) The committees shall each have their own rules of procedure, which shall be subject to the approval of the Federal Ministry of Justice and the Federal Republic of Germany. Federal Ministry of Food and Agriculture needs. The Rules of Business are published by the Federal Institute for Drugs and Medical Devices on its homepage on the Internet. Unofficial table of contents

§ 6

The annex to the Regulation, as amended on 19 April 2013, shall continue to apply to the relevant committee until such time as a new Rule of Procedure has been made publicly available pursuant to Article 5 (3), second sentence. Unofficial table of contents

§ 7 (omitted)

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§ 8

This Regulation shall enter into force on the day following the date of delivery. Unofficial table of contents

Final formula

The Federal Minister for Youth, Family and Health