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Regulation on the database-driven information system on orphan medicinal products of the German Institute for medical documentation and information (DIMDI drug regulation DIMDI-AMV) DIMDI AMV Ausfertigung date: 24.02.2010 full quotation: "DIMDI drug prescription from February 24, 2010 (BGBl. I p. 140), most recently by article 3 of the Decree of the 17th July 2015 (BGBl. I S. 1380) is changed" stand: last amended by article 3 V v. 17.7.2015 I 1380 more details to the stand number you find in the menu under notes *) § 3 paragraph 2 serves the implementation of article 40 paragraph 4 and Article 111 paragraph 6 and 7 of Directive 2001/83/EC of the European Parliament and of the Council of the 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311 of 28.11.2001, p. 67), most recently by the directive 2009/53/EC (OJ L 168 of the 30.6.2009, p. 33) is has been modified, and the implementation of article 44, paragraph 4 and article 80 paragraph 6 and 7 of Directive 2001/82/EC of the European Parliament and of the Council of the 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311 of 28.11.2001, p. 1), the last by Directive 2009/53/EC (OJ L 168 of the 30.6.2009, p. 33) has been changed.
Footnote (+++ text detection from: 27.2.2010 +++) (+++ official note of the standard authority on EC law: implementation of EGRL 83/2001 (CELEX Nr: 301 L 0083) EGRL 82/2001 (CELEX Nr: 301 L 0082) +++) input formula's Decree - the Ministry of health on the basis of § 67a paragraph 3 sentence 1 and 2 in connection with paragraphs 2 and 4 of the medicines Act, most recently by article 2 of the law of June 14, 2007 (BGBl. I S. 1066) is has been modified , in agreement with the Federal Ministry of the Interior, the Federal Ministry of Economics 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 paragraph 3 sentence 1 and 2 in conjunction with sentence 3 and paragraph 2 of the medicines Act, the last by article 2 of the law of June 14, 2007 (Federal Law Gazette I p. 1066) is has been modified , in agreement with the Federal Ministry of the Interior, the Federal Ministry of Economics and technology and the Federal Ministry of health and on the basis of article 47 (1 c) sentence 2 of the German medicines Act, most recently by article 1 of the law of 17 July 2009 (BGBl. I S. 1990) is has been modified in agreement with the Federal Ministry of health: article 1 nature and contents of the information system (1) in the central drug information system according to section 67a of the medicines Act are stored without prejudice to the requirements of other legal provisions : 1 data, also of personal style, about a) the licensing and registration status of pharmaceutical products, decisions under section 21, paragraph 4, of the German medicines Act, information collected in the framework of the authorisation or registration, including change indicators and the medical, pharmaceutical and pharmacological properties of medicines, drugs or other components, b) active ingredients and excipients used in the manufacture of medicinal products or have previously been used , c) phased plan procedure, d) State batch tests according to § 32 of the medicines Act, e) clinical trials with drugs for use in humans after the sixth section of the medicines Act, f) permits and certificates for tissue preparations according to section 21a of the medicines Act.
2. data, also of personal style, about a) permits according to § 13 of the German medicines Act, b) permits according to §§ 20 b and 20 c of the medicines Act, c) permits according to § 43 paragraph 1 sentence 1 of the German medicines Act, d) permits according to § 52a paragraph 1 of the German medicines Act, e) inspection results according to § 64 paragraph 3e and issue, refusal, withdrawal or revocation of certificates according to § 64 paragraph 3 g, f) ads according to article 67, paragraph 1 and 5 of the German medicines Act of pharmaceutical entrepreneurs , Wholesalers, testing laboratories and active ingredient distributors, g) permits according to § 72 of the medicines Act, h) certificates, permits or certificates according to § 72a, paragraph 1, sentence 1 number 1 and 2 and § 72 b paragraph 1 and 2 sentence 1 number 2 and 3 of the German medicines Act for the import of medicinal products or active substances from third countries, i) administrative measures according to the § § 69 and 69a of the medicines Act, which are for the monitoring of drug traffic by importance;
3. data according to § 47 paragraph 1 c rate 1 of the medicines Act on the dispensing of medicines, the a) substances with antimicrobial effect or b) substances in one of the plants of the regulation on substances with a pharmacological effect as amended by the notice of July 8, 2009 (BGBl. I S. 1768) are listed in the currently valid version as active ingredients, to veterinarians , even if the data is personally identifiable.
(2) in the drug information system more drug-related data, such as data on drug risks, sales volumes, prescription volume and traffic can be stored medicines installed package sizes, as far as this to fulfil the tasks of the German Institute for medical documentation and information or the authorities is required in article 3 paragraph 1.
(3) the generally accessible to the public information system for medicines contains data about product characteristics of medicinal products as well as information relating to medicines or their placing in context. These include in particular information about the approval status, leaflet and the prescribing information, the public assessment report as well as the name and address of responsible persons or companies as well as for medicinal products which are intended for use in humans, summaries of risk management plans, details of requirements together with deadlines and dates for compliance, referred to in article 23 of Regulation (EC) No 726 / 2004 in addition medicinal monitored the list of , the place the medicinal product on the market. The information system also contains information about the different ways for reporting suspected cases of adverse effects of medicinal products intended for use in humans, to the competent authorities by health professionals and patients as well as in article 25 of Regulation (EC) No. 726 / 2004 Internet forms for the notification of suspected cases of adverse reactions. Prejudice to the provisions on the protection of personal data, to the protection of intellectual property and the protection of operating and business secrets.
(4) the German Institute for medical documentation and information provides a widely accessible Internet portal to provide information about the legal framework of the shipping trade, including the hint that in the Member States of the European Union in terms of the classification and distribution of medicines, differences over the joint shipping trade logo, the list of companies for medicines intended for use in people, , offer the drug through mail order via the Internet, with indication of the respective Internet portals, as well as the risks associated with illegal mail order of medicines over the Internet.
§ 2 data transmission at the German Institute for medical documentation and information (1) without prejudice to the requirements of other statutory provisions provide the authorities responsible for enforcing the drug law of the Bund and the Länder at the German Institute for medical documentation and information in article 1 paragraph 1 number 1, 2, paragraph 2 and 3 referred to data by remote data transmission or on automated processable data carriers. The modalities, in particular the technical or operational requirements on data transmission, including the commencement date and period of delivery, are set 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 security in information technology is to participate.
(2) pharmaceutical entrepreneur and wholesalers provide that in article 1 paragraph 1 number 3 data referred to the German Institute for medical documentation and information by remote data transmission or automatically processable data carriers. This shall be indicated: 1 the annual total amount of, broken down by the first two digits of the postal code of the address of the respective veterinary surgeons, as well as 2 the registration number of each given medicinal product.
The data are to March 31 of the following year at the latest, to submit for the first time to March 31, 2012, for the year 2011. The German Institute for medical documentation and information determined in consultation with the Federal Office of consumer protection and food safety, as well as the other competent authorities of the Federal Government the immediate technical or operational requirements for data transmission, such as masks, formats, vocabularies, or disks to be used, and these requirements in the Federal Gazette is known; the Federal Office for security in information technology is to participate.
(3) the debtor pursuant to paragraphs 1 and 2 to the transmission of data to the German Institute for medical documentation and information are responsible for the correctness and completeness of the data transferred. If the transmission of the data corresponding to the respective State of the art measures to ensure data protection and data security to meet. In the case of the use of accessible networks are to apply encryption methods that correspond to the current state of technology.
§ 3 deployment provided of data and use of the information system (1) that are number 1 and 2 data stored in the information system according to § 1 paragraph 1 the federal ministries for the medicines and the radiation protection law, the federal upper authorities referred to in paragraph 77 of the medicines Act, as well as for enforcing the drug law and the drug investigation authorities of the countries to the polling. In the information system 1 to section 1 paragraph 1 number 3 letter of a stored data the federal authority referred to in article 77, paragraph 3 of the German medicines Act to the polling provided, 2. According to article 1, paragraph 1 number 3 2(a) and (b) stored data be supplied the Supreme Land authorities to retrieve.
In the case of theorem 2, item 2 does not the breakdown medicines that are approved only for poultry, providing for retrieval after the digits of the postal code of the address of the respective animal doctor. By way of derogation from sentence 3, providing for retrieval can capture also the breakdown after the digits of the postal code of the address of the respective animal doctor, if at any time ensure that the data 1 solely for the purpose of § 67a, paragraph 3a of the medicines Act of veterinary monitoring referred to uses and used 2 not for monitoring purposes. The demand by the mentioned point is permitted, insofar as this is necessary for the performance of their duties.
(2) the German Institute for medical documentation and information transmits the data according to § 1 paragraph 1 of the European Medicines Agency number 2 letter a, d, e, g and f with regard to the indication of active ingredient importers, manufacturers and retailers. The data according to § 1 paragraph 1 number 2 letter a not be delivered unless the manufacturing authorization only for medicated feedingstuffs has been granted.
(3) the German Institute for medical documentation and information can be assigned more tasks to the central provision of data or to the Central transfer of data to the European Medicines Agency within the framework of its statutory jurisdiction. The decision meets the Federal Ministry for health or, as far as medicines are concerned, intended for use in animals are the Federal Ministry of food, agriculture and consumer protection in agreement with the Federal Ministry of health. Case of notification and information obligations by agencies of the countries, the tasks in the agreement with the highest land authorities are assigned to.
(4) a submission in article 1 paragraph 1 number 1 and 2 data mentioned by the German Institute for medical documentation and information in other places is allowed, insofar as this is necessary for the performance of their duties and do not preclude the public concerns. Prejudice to the provisions on the protection of personal data, to the protection of intellectual property and the protection of operating and business secrets.
§ 4 retention period data according to § 1 para 1 Nos. 1 and 2 and paragraph 2 with the exception of personal data at least 30 years for the duration of the marketability of the medicinal product concerned, in the information system available are. Data according to § 1 paragraph 1 is number 3 to delete documentation and information no later than five years after they are sent to the German Institute for medical. Personal information not related to the marketability of a medicinal product in context, are not later than ten years after discontinuation of the event for their collection to delete. Personal data related to the marketability of a medicinal product in context, are to delete at the latest 15 years after the end of the marketability of the medicinal product concerned.
§ 5 is right to information article 19 of the Federal Data Protection Act to apply legal entities according to.
Article 6 entry into force this regulation enter into force on the day after the announcement.
Concluding formula the Federal Council has approved.
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