Pharmacopoeia Act 2012 - Abg 2012

Original Language Title: Arzneibuchgesetz 2012 - ABG 2012

Read the untranslated law here: https://www.global-regulation.com/law/austria/2997506/arzneibuchgesetz-2012---abg-2012.html

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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 one of the / made collection of recognized pharmaceutical rules on the definition, production, quality, composition, dosage, description, storage, delivery and testing of medicines, as well as the condition of containers and packages of medicinal products known by the Federal Minister of health.

(2) the pharmacopoeia comprises the European Pharmacopoeia under the Convention on the elaboration of a European Pharmacopoeia, BGBl. No. 181/1979, and the Austrian national pharmacopoeia.

Binding declaration and by-laws

2. (1) has the Federal Minister for health by regulation to declare binding the German version of the European Pharmacopoeia as a "European Pharmacopoeia, the official Austrian issue" and to be published by Edition at the Federal Ministry of health and the district administrative authorities. This is a free of charge public consultation to ensure.

(2) the Federal Minister of health has those regulations of the Austrian national pharmacopoeia, which cannot be replaced by the European Pharmacopoeia, the official Austrian issue, taking on the current state of the science, and taking into account the special needs of Austria by regulation as "Austrian Pharmacopoeia, official Edition" binding to explain. The Federal Minister of health is authorized to amend the rules of the European Pharmacopoeia, the official Austrian output, if necessary, by additional provisions in the Austrian pharmacopoeia.

Investigations

§ 3. The Austrian Agency for health and food security GmbH, AGES, is the competent Institute for professional studies in connection with the pharmacopoeia. If the AGES of the studies is not possible, this in other appropriate facilities can be made.

Preparation, testing and placing on the market

Medicines are § 4 (1) according to the rules contained in the pharmacopoeia to create, check, or to bring in traffic. This applies also for the quality of the containers listed in the Pharmacopoeia or wrappings, as long as those related to drugs directly in contact.

(2) in the case of the examination can be applied other methods and other devices used, as they are described in the Pharmacopoeia, if guaranteed according to the respective State of the science is proven to be achieved the same results as with the methods described in the pharmacopoeia and devices. Only other methods may be applied in the production if a monograph of the pharmacopoeia expressly allows for a different manufacturing process.

(3) if the pharmacopoeia contains no rules on the manufacture, testing and the placing on the market of medicinal products, containers or wrappings, is the current state of science to comply with.

Quality and identity checks

Who manufactures § 5 (1) containers referred to in article 4, paragraph 1 medicinal product or the or wrappings or checks, either perform quality checks provided for in the Pharmacopoeia or



1 to perform in establishments which have a corresponding authorisation in accordance with article 63, paragraph 1, medicines Act, Federal Law Gazette No. 185/1983, or 2. in establishments which have a corresponding licence from a competent authority of another party of the European economic area, or 3rd in pharmacies.

(2) the obligation provided for in paragraph 1 is not, if there are already appropriate test certificates on the implementation of the quality checks provided for in the pharmacopoeia.

(3) who gives out medicines to final consumers, has carried out identity checks provided for in the pharmacopoeia. A check of identity is to perform, even if the pharmacopoeia contains no relevant information. Distribution of medicinal products, such identity checks are not required.

(4) records in written or electronic form are lead on the audits carried out in accordance with paragraphs 1 and 3, which have to contain at least the following information:



1 date of sample receipt and date of beginning and end of the test, 2. name of the medicinal product or the container or serving, 3. supplied or manufactured in the amount, 4. name and address of the supplier, 5. results of a Visual check of excess packaging and delivery, 6 batch number, 7 type and result of checking and 8 signature of the / of the examiners.

The records are to be kept by the last dated signature at least five years. The data stored in electronic form can be exposed at any time in human-readable form.

Pharmacopoeia Commission

Section 6 (1) of the Federal Ministry of health establishes a Pharmacopoeia Commission. The Pharmacopoeia Commission has the / the Federal Ministers of health in meeting him or her in accordance with the § to advise § 1 and 2 whether tasks.

(2) the Pharmacopoeia Commission have as members to belong to:



1. each a representative of the areas of expertise of a) pharmaceutical chemistry, b) pharmacognosy, c) Pharmacology, d) pharmaceutical technology, e) hygiene and f) veterinary medicine;

2. three expert officials of the Federal Ministry of health;

3. a representative of the Federal Ministry for defence and sports;

4. three expert on agendas of drug safety and quality staff of the AGES;

5. each two representatives a) the Austrian Chamber of pharmacists and b) of the Wirtschaftskammer Österreich;

6 per a representative a) the Austrian Medical Association, b) of the Austrian Chamber of dentists, c) the Austrian Veterinary Association, d) of the main Association of Austrian social insurance institutions, e) the Chamber of agriculture in Austria, f) of the Federal Chamber of labour and g) of the Austrian Trade Union Federation.

(3) for each Member a/is a Deputy is appointed. The members and their representatives are from the / to be appointed by the Federal Minister of health for a period of five years. With regard to the referred to in par. 2 Nos. 3, 5, and 6 representatives proposal is entitled to the relevant institutions.

(4) the deliberations of the Pharmacopoeia Commission can be consulted, where appropriate, other experts.

(5) the Federal Minister of health has servants/officials one/one for the time referred to paragraph 3 to entrust their Ministry or the AGES with the chairmanship of the Pharmacopoeia Commission.

(6) the deliberations of the Pharmacopoeia Commission are for one of the / to lead by the Federal Minister of health to adopt rules of procedure.

(7) the activity in the Pharmacopoeia Commission is Honorary. Any travel costs are the highest level of fees the travel fees regulation Pharmacopoeia Commissioners or their deputies and experts in 1955, BGBl. No. 133, to replace.

Penal provisions

7. (1) if



1 medicinal products or containers or wrappings meet the requirements laid down in § 4 manufactures, checks or brings in traffic, or 2 not performs the quality checks provided for in the pharmacopoeia contrary to § 5 paragraph 1 or do not perform can be, or emits 3. medicinal violates article 5 par. 3 without identity verification to final consumers, or contravenes the recording obligations pursuant to section 5, paragraph 4 4., commits, unless the Act constitutes not a criminal offence falling within the jurisdiction of the courts , an administrative offence and is fined up to 3 600 euro in case of recurrence with a fine to punish up to 7 200 euros.

(2) an attempt is punishable.

Final provisions

As far as the Federal law refers to provisions of other federal laws, these provisions are section 8 (1) in their currently valid version to apply.

(2) with entry into force of this Federal Act is the Federal law of 17 April 1980 on the Pharmacopoeia (Pharmacopoeia Act), Federal Law Gazette No. 195/1980, override.

§ 9. The Federal Minister for health is entrusted with the execution of this Federal Act.

Fischer

Faymann