Medical Specialty Register 2013

Original Language Title: Arzneispezialitätenregister 2013

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277. Ordinance of the Federal Minister of Health on the Register of Medicinal Specialities 2013

On the basis of § 27 (3) of the German Medicines Act, BGBl. No. 185/1983, as last amended by the Federal Law BGBl. I No 162/2013, shall be assigned:

§ 1. The Federal Office for Health and Safety (Bundesamt für Sicherheit im healthcare) is responsible for a register of medicinal products in which each

1.

Authorisation of a proprietary medicinal product,

2.

Registration of a proprietary medicinal product

3.

Marketing authorisation for parallel import,

4.

Modification and transfer of an authorisation, registration or marketing authorisation for parallel import, and

5.

Cancellation of an admission, registration or approval for the distribution in parallel import

is to be entered. In addition, the Register of Proprietary Medicinal Products has to contain all proprietary medicinal products which are considered to be approved in accordance with Section 88 (1) of the Medicines Act.

§ 2. (1) The entries in accordance with § 1 Z 1 and 2 shall be published with the following data:

1.

Authorisation and/or registration number,

2.

the name of the proprietary medicinal product;

3.

Authorisation and/or Registration-holder,

4.

information on the extent to which the dispensing of the proprietary medicinal product is subject to the prescription or to the rules on addiction,

5.

Composition according to the type and amount of those components which have an effect on the efficacy, tolerability or durability of the proprietary medicinal product; and

6.

in the case of proprietary medicinal products for use in animals, whether a withdrawal period is required, or that the proprietary medicinal product must not be used in animals from which foods or medicinal products can be obtained.

(2) The entries in accordance with § 1 Z 3 shall be published, stating the following data:

1.

Authorisation and/or Registration number according to § 4 para. 3,

2.

the name of the proprietary medicinal product;

3.

Marketing authorisation holder for parallel import,

4.

indication of the extent to which the dispensing of the proprietary medicinal product is subject to the prescription or to the rules on addictive toxins; and

5.

Export country.

§ 3. The publications referred to in § 2 shall be published without delay, but no later than two months after the legal validity of the authorisation. Registration of the proprietary medicinal product or the marketing authorisation for the parallel import, its modification, transfer or cancellation on the homepage of the Federal Office for Safety in Health Care.

§ 4. (1) For entries in accordance with § 1 Z 1 to 3, a registration or registration is required for each proprietary medicinal product. Authorisation number to be assigned.

(2) For proprietary medicinal products, the registration or Authorisation numbers shall be given after the following classification:

1.

for proprietary medicinal products authorised in accordance with Article 7 of the Medicinal Products Act, provided that they are not proprietary medicinal products within the meaning of Z 2 to 4, 8 and 9, numbers 100001 to 199999,

2.

for biogenic proprietary medicinal products, from 200001 to 299999,

3.

for authorised homeopathic proprietary medicinal products, numbers 300001 to 399999,

4.

for radioactive proprietary medicinal products, numbers 400001 to 499999,

5.

for registered apothecary proprietary medicinal products, the numbers 500001 to 599999,

6.

for registered homeopathic proprietary medicinal products, numbers 600001 to 699999,

7.

for registered traditional herbal medicinal products, numbers 700001 to 799999,

8.

in the case of medicinal products for use in animals, numbers 800001 to 899999; and

9.

in the case of authorised pharmacopoitic monographs, the numbers 900001 to 999999.

(3) proprietary medicinal products for which a parallel import marketing authorisation has been granted shall be subject to the approval number of the relevant approved or approved marketing authorisation holder. to include registered proprietary medicinal products (reference authorisation). This is to be supplemented by the letter P and the series.

§ 5. The register of proprietary medicinal products shall be carried out by means of electronic data processing.

§ 6. (1) With the entry into force of this Regulation, the Federal Minister of Health and Women's Regulation on the Register of Proprietary Medicinal Products 2006, BGBl, shall enter into force. II No 21/2006, as last amended by BGBl. II No 79/2010, except for force.

(2) The registration or Registration numbers of proprietary medicinal products awarded in accordance with § 6 of the Ordinance of the Federal Minister for Health and Women on the Register of Proprietary Medicinal Products 2006 continue to be maintained. These do not have to comply with § 4 of this Regulation.

Stöger