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Regulation on the database-based information system on medicinal products of the German Institute for Medical Documentation and Information

Original Language Title: Verordnung über das datenbankgestützte Informationssystem über Arzneimittel des Deutschen Instituts für Medizinische Dokumentation und Information

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Regulation on the database-supported information system on medicinal products of the German Institute for Medical Documentation and Information (DIMDI-Ordinance on Medicinal Products for Medical Devices-DIMDI-AMV)

Unofficial table of contents

DIMDI AMV

Date of completion: 24.02.2010

Full quote:

" DIMDI Pharmaceutical Ordinance of 24 February 2010 (BGBl. 140), as last amended by Article 3 of the Regulation of 17 July 2015 (BGBl I). I p. 1380).

Status: Last amended by Art. 3 V v. 17.7.2015 I 1380

For more details, please refer to the menu under Notes
*)
Article 3 (2) provides for the implementation of Article 40 (4) and Article 111 (6) and (7) of Directive 2001 /83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 327, 22.12.2001, p. 67), which was last amended by Directive 2009 /53/EC (OJ L 311, 28.11.2009, p. 33), and of the implementation of Articles 44 (4) and 80 (6) and (7) of Directive 2001 /82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to Veterinary medicinal products (OJ L 327 1), as last amended by Directive 2009 /53/EC (OJ L 311, 28.11.2009, p. OJ L 168, 30.6.2009, p. 33).

Footnote

(+ + + Text proof: 27.2.2010 + + +) 
(+ + + Official note from the norm-provider on EC law:
Implementation of the
ERL 83/2001 (CELEX Nr: 301L0083)
ERL 82/2001 (CELEX Nr: 301L0082) + + +)

Unofficial table of contents

Input formula

Order it
-
the Federal Ministry of Health on the basis of § 67a (3) sentence 1 and 2 in conjunction with paragraphs 2 and 4 of the Medicines Act, most recently by Article 2 of the Law of 14 June 2007 (BGBl. 1066), in agreement with the Federal Ministry of the Interior, the Federal Ministry for Economic Affairs and Technology and the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety,
-
the Federal Ministry of Food, Agriculture and Consumer Protection on the basis of § 67a (3) sentence 1 and 2 in conjunction with sentence 3 and paragraph 2 of the Medicines Act, the last of which is provided by Article 2 of the Law of 14 June 2007 (BGBl. 1066), in agreement with the Federal Ministry of the Interior, the Federal Ministry of Economic Affairs and Technology and the Federal Ministry of Health and on the basis of Section 47 (1c) sentence 2 of the Medicines Act, which most recently Article 1 of the Law of 17 July 2009 (BGBl. 1990), in agreement with the Federal Ministry of Health:
Unofficial table of contents

§ 1 Art and content of the information system

(1) In the central medicinal product information system according to § 67a of the Medicines Act, without prejudice to the requirements of other statutory provisions, the following are stored:
1.
Data, including personal data, on:
a)
the marketing authorisation and registration status of medicinal products, decisions pursuant to § 21 (4) of the Medicines Act, particulars that have been collected in the course of the authorisation or registration, including information on change advertisements and the medical, pharmaceutical and pharmacological properties of medicinal products, active substances or other ingredients,
b)
active substances and other ingredients used in the manufacture of medicinal products or used in the past,
c)
the stage plan procedure;
d)
state batch tests in accordance with § 32 of the Medicines Act,
e)
clinical trials of medicinal products for use in humans according to the Sixth Section of the Medicines Act,
f)
Authorisations and certificates of tissue preparations in accordance with Article 21a of the Medicinal Products Act;
2.
Data, including personal data, on:
a)
Authorisations according to § 13 of the Medicines Act,
b)
§ § 20b and 20c of the Medicines Act,
c)
Authorisations pursuant to § 43 (1) sentence 1 of the German Medicines Act,
d)
Authorisations pursuant to Section 52a (1) of the Medicines Act,
e)
Inspection results according to § 64 paragraph 3e and the exhibition, failure, withdrawal or revocation of certificates pursuant to § 64 paragraph 3g,
f)
Advertisements in accordance with § 67 (1) and (5) of the Medicines Act of pharmaceutical companies, wholesalers, test laboratories and active substance dealers,
g)
Authorisations pursuant to § 72 of the German Medicines Act,
h)
Certificates, permits or certificates pursuant to section 72a (1), first sentence, points 1 and 2, and § 72b (1) and 2 (1) (2) and (3) of the Medicines Act for the importation of medicinal products or active substances from third countries,
i)
regulatory measures in accordance with § § 69 and 69a of the Medicines Act, which are of importance for the supervision of pharmaceutical transport;
3.
Data in accordance with Section 47 (1c), first sentence, of the Medicines Act on the supply of medicinal products, which
a)
anti-microbial agents or
b)
Substances contained in one of the annexes to the Regulation on substances having a pharmacological effect, as amended by the Notice of 8 July 2009 (BGBl. 1768), as amended in each case, as active substances
to veterinarians, even as far as the data are personal.
(2) The medicinal product information system may store further medicinal product-related data, such as data on the risks of medicinal products, sales volumes, prescription volumes and pack sizes of medicinal products placed on the market, to the extent that this is the case. The tasks of the German Institute of Medical Documentation and Information, or the authorities referred to in § 3 (1), are required. (3) The information system for medicinal products accessible to the general public contains: Data on product characteristics of medicinal products and information provided with: medicinal products or their placing on the market. These include, in particular, the authorisation status, the package leaflet and the technical information, the public assessment report, and the medicinal products intended for use in humans, summaries of Risk management plans, information on requirements, together with deadlines and dates for compliance, the list of medicinal products additionally monitored under Article 23 of Regulation (EC) No 726/2004, and the name and address of each of the medicinal products concerned responsible persons or undertakings which place the medicinal product on the market. The information system shall also contain information on the different ways in which cases of suspected adverse reactions of medicinal products intended for use in humans are reported to the competent authorities by members of the Health professionals and patients, as well as the Internet forms referred to in Article 25 of Regulation (EC) No 726/2004 for the reporting of suspected cases of suspected adverse reactions. The provisions on the protection of personal data, the protection of intellectual property and the protection of operational and business secrets remain unaffected. (4) The German Institute for Medical Documentation and Information provides for Medicinal products intended for use in human beings, a generally accessible Internet portal providing information on the legal framework conditions of the mail order trade, including the indication that the Member States of the European Union differences with regard to the classification and delivery of medicinal products may consist of the common mail order logo, the list of undertakings offering medicinal products via the Internet by means of mail order, indicating the respective Internet portals and the risks associated with the use of the Internet; illegal distribution of medicinal products via the Internet. Unofficial table of contents

§ 2 Data transfer to the German Institute for Medical Documentation and Information

(1) Without prejudice to the requirements of other statutory provisions, the competent authorities of the Federal Government and the Länder responsible for the implementation of the Medicines Act shall transmit to the German Institute for Medical Documentation and Information the German Institute for Medical Documentation and Information in accordance with § 1 (1) (1), (2), (2) and (3) by means of remote data transmission or by means of automated processing of data carriers. The detailed details, in particular the technical or function-related requirements for data transmission, including the beginning and the period of transmission, shall be provided by the German Institute for Medical Documentation and Information in agreement with the competent authorities of the federal and state governments; the Federal Office for Information Security (Bundesamt für Sicherheit in der Informationstechnik) is to be involved. (2) Pharmaceutical entrepreneurs and wholesalers shall transmit the information in § 1 paragraph 1 number 3 mentioned data from the German Institute for Medical Documentation and Information by remote data transmission or on automatable data carriers. The following shall be stated:
1.
the total quantity delivered each year, broken down by the first two digits of the postal code of the address of the veterinary surgeon, and
2.
the marketing authorisation number of the medicinal product concerned.
The data shall be submitted no later than 31 March of the following year, for the first time at 31 March 2012 for the year 2011. The German Institute for Medical Documentation and Information, in agreement with the Federal Office of Consumer Protection and Food Safety, and the other competent federal authorities, shall determine the technical or technical details of the Federal Office for Medical Documentation and Information. function-related requirements for data transmission, such as input masks, formats, vocabularies or data carriers to be used, and makes these requirements known in the Federal Gazette; the Federal Office for Information Security (Bundesamt für Sicherheit in der Informationstechnik) is to be (3) The participation in the transmission of the data to the German pursuant to paragraphs 1 and 2 Institute of Medical Documentation and Information Boys are responsible for the correctness and completeness of the transmitted data. In the transmission of the data, corresponding measures are to be taken to ensure data protection and data security in the respective state of the art. In the case of the use of generally accessible networks, encryption methods shall be used which correspond to the state of the art. Unofficial table of contents

§ 3 Provision of data and use of the information system

(1) The data stored in the information system in accordance with Section 1 (1) (1) and (2) shall be the federal ministries responsible for the pharmaceutical law and radiation protection law, the federal authorities referred to in § 77 of the Medicines Act, and made available to the countries responsible for the enforcement of the Medicines Act and for the investigation of medicinal products in the countries concerned. Those in the information system
1.
the data stored in accordance with section 1 (1) (3) (a) shall be made available to the federal authority referred to in § 77 (3) of the Medicines Act,
2.
Data stored in accordance with section 1 (1) (3) (a) and (b) shall be made available to the competent national competent authority for retrieval.
In the case referred to in point 2 (2), in the case of medicinal products which are authorised exclusively for poultry, the provision for retrieval does not cover the breakdown by number of postal codes of the address of the veterinary surgeon concerned. By way of derogation from the third sentence, the provision for retrieval may also cover the breakdown by number of the postal codes of the address of the respective veterinarian, provided that it is ensured at any time that the data are available
1.
is used exclusively for the purpose of the veterinary medicinal product monitoring referred to in Article 67a (3a) of the Medicines Act; and
2.
not used for surveillance purposes
. Retrieval by the aforementioned bodies is permitted insofar as this is necessary for the performance of their tasks. (2) The German Institute for Medical Documentation and Information shall transmit the data to the European Medicines Agency according to § 1 Paragraph 1 (2) (a), (d), (e), (g) and (f) with a view to the advertising of active agents, producers and distributors. The data referred to in Article 1 (1) (2) (a) shall not be transmitted to the extent that the manufacturing authorization has been granted only for medicated feedingstuffs. (3) The German Institute for Medical Documentation and Information can be used within the framework of its The European Medicines Agency will be responsible for further tasks for the central provision of data for or for the central transmission of data to the European Medicines Agency. The decision is taken by the Federal Ministry of Health or, in so far as medicinal products are concerned, which are intended for use in animals, the Federal Ministry of Food, Agriculture and Consumer Protection, in agreement with the Federal Ministry of Food, Agriculture and Consumer Protection. Federal Ministry of Health. In the case of participation and teaching duties of the authorities of the Länder, the tasks shall be assigned in agreement with the competent national authorities. (4) A transmission of the data referred to in § 1 (1) (1) and (2) by the German Institute for Medical Documentation and Information to other bodies is permissible, insofar as this is necessary for the performance of their tasks and for which public matters are not in conflict. The provisions relating to the protection of personal data, the protection of intellectual property and the protection of operational and commercial secrets shall remain unaffected. Unofficial table of contents

§ 4 retention period

Data in accordance with Article 1 (1) (1) and (2) and (2), with the exception of personal data, shall be available for at least 30 years beyond the duration of the traffic capacity of the medicinal product concerned in the information system. Data in accordance with § 1 (1) (3) shall be deleted no later than five years after being transmitted to the German Institute of Medical Documentation and Information. Personal data which are not related to the transport capacity of a medicinal product shall be deleted no later than 10 years after the departure of the occasion for their collection. Personal data relating to the ability to transport a medicinal product shall be deleted no later than 15 years after the end of the transport capacity of the medicinal product concerned. Unofficial table of contents

§ 5 Right to information

§ 19 of the Federal Data Protection Act is to be applied accordingly to legal persons. Unofficial table of contents

§ 6 Entry into force

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

Final formula

The Federal Council has agreed.