Regulation On The Database-Driven Information System On Orphan 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-Pharmaceutical Ordinance-DIMDI-AMV)

Table of Contents

DIMDI-AMV

Date of expiry: 24.02.2010

Full quote:

" DIMDI-Medicines Ordinance of 24. February 2010 (BGBl. 140), as last amended by Article 3 of the Regulation of 17 June 2008. July 2015 (BGBl. I p. 1380) has been changed "

:Last modified by Art. 3 V v. 17.7.2015 I 1380

For details, see the menu under Notes
*)
§ 3 Paragraph 2 is used for the implementation of Articles 40 (4) and 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, 28.12.2001, p. 67), which was last amended by Directive 2009 /53/EC (OJ L 311, 28.11.2009, p. 33), and 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 June 2001 on the implementation of the European Economic and Financial Regulation (EC) No 178/EC of the European Parliament and of the Council of 6 June 2009 November 2001 on the Community code relating to veterinary medicinal products (OJ L 327, 28.12.2001, p. 1), as last amended by Directive 2009 /53/EC (OJ L 311, 28.11.2009, p. 33).

Footnote

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

unofficial table of contents

input formula

It is
-
The Federal Ministry of Health on the basis of § 67a (3) sentence 1 and 2 in conjunction with paragraphs 2 and 4 of the Medicinal Products Act, most recently established 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 Medicinal Products Act, which most recently 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:
Non-official contents of the table of contents

§ 1 Art and content of the Information systems

(1) In the Central Medicines Information System according to § 67a of the Medicines Act, without prejudice to the requirements of other statutory provisions:
1.
Data, also of a personal nature, about
a)
the marketing authorisation and registration status of medicinal products, decisions pursuant to § 21 (4) of the Medicinal products act, information collected in the course of registration or registration, including information on change indications 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)
Step planning method,
d)
State batch audits according to § 32 of the Medicinal Products Act,
e)
Clinical trials of medicinal products for use in humans according to the Sixth Section of the Medicines Act,
f)
Approvals and certifications of tissue preparations according to § 21a of the Medicines Act;
2.
data, also of a personal nature, over
a)
Permits according to § 13 of the Medicines Act,
b)
Permits according to § § 20b and 20c of the German Medicines Act Pharmaceuticals Act,
c)
Permits according to § 43 (1) sentence 1 of the Medicines Act,
d)
Permits according to § 52a (1) of the Medicines Act,
e)
Inspection results pursuant to § 64 paragraph 3e and the issuing, revocation, withdrawal or revocation of certificates pursuant to § 64 paragraph 3g,
f)
Ads pursuant to § 67 (1) and (5) of the Medicinal Products Act of pharmaceutical companies, wholesalers, test laboratories and drug dealers,
g)
authorisations according to § 72 of the Medicines Act,
h)
Certificates, permissions or certificates according to § 72a (1), first sentence, points 1 and 2, and § 72b (1) and 2 (1) (2) and (3) of the Medicines Act for the import of Medicinal products or active substances from third countries,
i)
Government measures in accordance with § § 69 and 69a of the Medicines Act, which are responsible for the supervision of medicinal products
3.
Data pursuant to § 47 (1c), first sentence, of the Medicines Act on the release of medicinal products which are
a)
antimicrobials or
b)
Substances used in one of the annexes to the Regulation on substances with a pharmacological effect as amended by the 8. July 2009 (BGBl. I p. 1768), as amended, as active substances
, to veterinarians, even to the extent that the data are personal.
(2) In the medicinal product information system, other medicinal product-related data may be used, such as: Data on the risks of medicinal products, sales volumes, prescription volumes and pack sizes of medicinal products placed on the market shall be stored, insofar as this is necessary for the performance of the tasks of the German Institute for Medical Documentation and Information or the authorities referred to in Article 3 (1).(3) The general information system for medicinal products available to the public shall include data on product characteristics of medicinal products and information relating to 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 pursuant to 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 relating to the protection of personal data, the protection of intellectual property and the protection of operational and commercial secrets shall remain unaffected.(4) The German Institute for Medical Documentation and Information provides a generally accessible internet portal for medicinal products intended for use in humans, with information on the legal framework conditions the transit trade, including the indication that differences in the classification and distribution of medicinal products may exist in the Member States of the European Union, the common mail order logo, the list of Companies that offer medicinal products through the Internet via the Internet, with details of the respective Internet portals and the risks associated with the illegal distribution of medicinal products via the Internet. Non-official 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 shall transmit to the German Institute for Medical Documentation and Information the competent authorities of the Federal Republic of Germany and the Länder responsible for the enforcement of the Medicinal Products Act as referred to in § 1 (1) (1), 2, (2) and (3), by remote data transmission or by means of automated 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 federal and state authorities; the Federal Office for Information Security (Bundesamt für Sicherheit in der Informationstechnik) is to be involved.(2) Pharmaceutical companies and wholesalers shall transmit the data referred to in Section 1 (1) (3) to the German Institute for Medical Documentation and Information by remote data transmission or on automated processing media. where
1.
means the total quantity delivered each year, broken down by the first two digits of the postcode of the address of the veterinary surgeon, as well as
2.
the marketing authorisation number of the medicinal product concerned.
The data shall be at the latest by 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 participate.(3) The data supplied pursuant to paragraphs 1 and 2 for the transmission of the data to the German Institute for Medical Documentation and Information shall be responsible for the correctness and completeness of the data transmitted. 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. Non-official table of contents

§ 3 Provision of data and use of the information system

(1) The information provided in the information system in accordance with § 1, paragraph 1 Number 1 and 2 stored data will 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 the Federal Ministry for the Law of Medicine and the German Medicines Act, and the Federal Ministry of Education and the authorities of the countries responsible for the investigation of medicinal products are made available for retrieval. The data stored in the information system
1.
in accordance with Article 1 (1) (3) (a) shall be the data stored in § 77 (3) of the German Medicines Act (Bundesoberbehörde) provided for retrieval,
2.
data stored in accordance with § 1 (1) (3) (a) and (b) shall be made available to the
In the case referred to in point 2 (2), for medicinal products authorised exclusively for poultry, the provision for retrieval does not cover the breakdown by reference to the figures of the Postal code of the address of the respective veterinary surgeon. By way of derogation from the third sentence, the provision for retrieval may also cover the breakdown by number of postal codes of the address of the respective veterinarian, provided that it is ensured at any time that the data is
1.
for the sole purpose of the article referred to in § 67a (3a) of the Medicines Act Veterinary medicinal products are used and
2.
are not used for monitoring purposes
. The retrieval by the said bodies shall be permitted as far as this is necessary for the performance of their tasks.(2) The German Institute for Medical Documentation and Information shall transmit to the European Medicines Agency the data referred to in Article 1 (1) (2) (a), (d), (e), (g) and (f) with a view to the advertising of active agents, manufacturers and manufacturers and traffickers. 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, within the scope of its legal competence, further tasks for the central provision of data for or for the central transmission of data to the European Union. Pharmaceutical Agency shall be assigned to the 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 bodies of the Länder, the tasks shall be assigned in agreement with the competent supreme state authorities.(4) The German Institute for Medical Documentation and Information shall transmit the data referred to in § 1 (1) (1) and (2) to other bodies, insofar as this is necessary for the performance of their tasks and in so far as they are public. Do not stand in the way of matters. 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. Non-official table of contents

§ 4 retention period

Data in accordance with § 1 (1) (1) and (2) and (2), with the exception of personal data, shall be shall be available for at least 30 years beyond the duration of the transport 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. Non-official table of contents

§ 5 Right of information

§ 19 of the Federal Data Protection Act applies accordingly to legal entities. Non-official table of contents

§ 6 Entry into force

This Regulation enters into force the day after the announcement. Non-official table of contents

Final formula

The Bundesrat has agreed.