Pharmacopoeia Act 2012 - Abg 2012

Original Language Title: Arzneibuchgesetz 2012 - ABG 2012

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44. Federal Law on the Pharmacopoeia (Pharmacopoeia Act 2012-ABG 2012)

The National Council has decided:

Definitions

§ 1. (1) The Pharmacopoeia is a collection of recognised pharmaceutical rules on the definition, production, quality, composition, dosage, designation, storage, dispensing and testing of Medicinal products, as well as the nature of containers and envelopes of medicinal products.

(2) The pharmacopoeia consists of the European Pharmacopoeia according to the Convention on the elaboration of a European Pharmacopoeia, BGBl. No. 181/1979, and the Austrian Pharmacopoeia.

Binding declaration and customer service

§ 2. (1) The Federal Minister for Health has to declare the German version of the European Pharmacopoeia as a "European Pharmacopoeia, Official Austrian Edition" by means of a regulation and by obligation to the Federal Ministry for Health in the case of health and the district administration. Free public consultation shall be ensured.

(2) The Federal Minister for Health has the provisions of the Austrian Pharmacopoeia, which are not replaced by the European Pharmacopoeia, Official Austrian Edition, on the basis of the respective status of the Austrian Pharmacopoeia. To make science and, taking into account the special requirements of Austria, a binding declaration as an "Austrian Pharmacopoeia, Official Edition". The Federal Minister for Health is authorized to supplement the regulations of the European Pharmacopoeia, the official Austrian edition, if necessary by additional regulations in the Austrian Pharmacopoeia.

Investigations

§ 3. The Austrian Agency for Health and Food Safety GmbH, AGES, is the competent institute for technical investigations in connection with the pharmacopoeia. If the AGES is not able to carry out the investigations, they can be carried out in other suitable facilities.

Manufacture, testing and placing on the market

§ 4. (1) Medicinal products shall be manufactured, tested or placed on the market in accordance with the rules laid down in the Pharmacopoeia. This shall also apply to the nature of the containers or sheaths listed in the pharmacopoeia, provided that they are directly in contact with medicinal products.

(2) In the course of the examination, other methods may also be used and other equipment used when they are described in the Pharmacopoeia, provided that, according to the respective state of the scientific community, it is guaranteed that the same results as those obtained with the the methods and devices described in the Pharmacopoeia. In the case of manufacture, other methods may only be used, provided that a monograph of the pharmacopoeia expressly permits a different production process.

(3) Where the pharmacopoeia does not contain any rules on the manufacture, testing and placing on the market of medicinal products, containers or sheaths, the state of the scientific knowledge in question shall be complied with.

Quality and identity checks

§ 5. (1) Any person who manufactures or inspects any medicinal product or the containers or envelopes referred to in § 4 (1) shall carry out the quality tests provided for in the Pharmacopoeia itself, or

1.

in establishments which have a corresponding authorization pursuant to Section 63 (1) of the German Medicines Act (BGBl). No 185/1983, or

2.

in establishments which have a corresponding authorization by a competent authority of another Contracting Party to the European Economic Area, or

3.

in pharmacies

by the Commission.

(2) The obligation laid down in paragraph 1 does not exist if there are already corresponding test certificates for the performance of the quality checks provided for in the pharmacopoeia.

(3) Those who make medicinal products to the final consumer shall carry out the identity checks provided for in the pharmacopoeia. A test for identity shall also be carried out if the pharmacopoeia does not contain any information on this subject. Such identity checks are not required in the delivery of proprietary medicinal products.

(4) In respect of the tests carried out in accordance with paragraphs 1 and 3, records shall be kept in writing or in electronic form, which shall contain at least the following information:

1.

the date of receipt of the sample and the date of commencement and completion of the test;

2.

the name of the medicinal product or of the container or of the packaging;

3.

Quantity delivered or produced in use,

4.

the name and address of the supplier;

5.

Result of a visual inspection of the overpackaging and delivery,

6.

batch number,

7.

the nature and outcome of the examination; and

8.

Signature of the examiner.

The records shall be kept for at least five years from the last dated signature. The data stored in electronic form must be made available at any time in a legible form.

Commission

§ 6. (1) The Federal Ministry of Health shall set up a pharmacopoitic commission. The Pharmacopoe Commission has to advise the Federal Minister for Health in the performance of the tasks assigned to him/her in accordance with § § 1 and 2.

(2) The Pharmacopoe Committee shall be members of the Commission:

1.

One representative/one representative of the subject

a)

Pharmaceutical chemistry,

b)

Pharmacognosy,

c)

Pharmacology,

d)

Pharmaceutical technology,

e)

Hygiene and

f)

veterinary medicine;

2.

three expert staff members of the Federal Ministry of Health;

3.

a representative of the Federal Ministry of Defence and Sport;

4.

three staff members of the AGES in relation to the safety and quality of medicinal products;

5.

Two representatives each

a)

the Austrian Pharmacerkammer and

b)

the Austrian Economic Chamber;

6.

One/one representative each

a)

the Austrian Medical Association,

b)

the Austrian Dentists ' Chamber,

c)

the Austrian Tierärztekammer,

d)

the main association of the Austrian social insurance institutions,

e)

the Austrian Chamber of Agriculture,

f)

the Federal Chamber of Labour and

g)

of the Austrian Trade Union Confederation.

(3) For each member, one/one alternate is to be ordered. The members and their alternates are to be ordered by the Federal Minister for Health for a period of five years. With regard to the representatives referred to in paragraph 2 (2), (3), (5) and (6), the institutions concerned shall be entitled to the right of proposal.

(4) Other experts may be consulted, where appropriate, in the proceedings of the Pharmacopoe Commission.

(5) The Federal Minister for Health shall be responsible for the time referred to in paragraph 3 to appoint a servant/servant of his or her ministry or AGES with the chairmanship of the Pharmacopoe Commission.

(6) The deliberations of the Pharmacopoe Commission shall be carried out in accordance with a point of order to be adopted by the Federal Minister for Health.

(7) The activity in the Pharmacopoe Committee is voluntary. Any travel expenses shall be paid to the members of the Pharmacopoa Commission or their deputists and to the experts who have been attached to it at the highest fee level of the travel fee rule in 1955, BGBl. No 133.

Criminal provisions

§ 7. (1) Who

1.

Manufacture, test or place on the market medicinal products or containers or sheaths contrary to the requirements laid down in § 4, or

2.

the quality checks provided for in the pharmacopoeia are not carried out or are not carried out in accordance with Article 5 (1), or

3.

Deliver medicines to the final consumer without identity verification, contrary to § 5 para. 3, or

4.

the recording requirements in accordance with § 5 (4) are contrary to the requirements of the

provided that the act does not constitute the offence of a criminal offence within the jurisdiction of the courts, an administrative surrender and a fine of up to EUR 3 600, in the event of a recurrence with a fine of up to 7 200 To punish the euro.

(2) The attempt is punishable.

Final provisions

§ 8. (1) As far as this federal law refers to provisions of other federal laws, these provisions shall be applied in their respectively applicable version.

(2) With the entry into force of this Federal Act, the Federal Act of 17 April 1980 on the Pharmacopoeia (Pharmacopoeia Act), BGBl. No. 195/1980, except for force.

§ 9. The Federal Minister of Health is responsible for the enforcement of this federal law.

Fischer

Faymann