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299. Regulation of the Federal Minister for health, Pharmakovigilanzanforderungen and Pharmakovigilanzmeldungen (pharmacovigilance regulation 2013 - 2013 PhVO)
On the basis of §§ 75a, 75 g ABS. 1 and § 94 h paragraph 7 and 8 of the medicines Act, Federal Law Gazette No. 185/1983, as last amended by Federal Law Gazette I no. 48/2013, is prescribed:
§ 1. This Regulation shall in accordance with the following provisions application to 1 human - approved in traffic brought human and animal medicines, 2. and animal medicinal, 3 registered traditional herbal medicinal products, 4. registered pharmacy own medicinal and 5 whose components.
2. (1) is "Guide" created by the European Commission and in band guide on pharmacovigilance regarding veterinary medicinal products published 9 b of regulation of pharmaceutical products in the European Union.
(2) "Pharmakovigilanzverantwortliche/Pharmakovigilanzverantwortlicher" is a person responsible for pharmacovigilance and qualified in accordance with section 7.
(3) "Adverse reaction a human medicinal product" is a noxious and unintended response to the drug.
(4) 'Adverse reaction of a veterinary medicinal product' is a harmful and unintended response to the drug, which occurs at doses normally used in animals for the prophylaxis, diagnosis or therapy of disease or the modification of physiological function.
(5) 'Adverse reaction in humans' is a reaction which is noxious and unintended and occurs in humans following exposure to a veterinary medicinal product.
(6) "Serious side effect of a veterinary medicinal product" means an adverse reaction which is fatal or life-threatening, to significant disability or disability, congenital anomalies or birth defects in the next generation causes or induces or prolonged signs in the animals treated.
(7) "Unexpected adverse reaction" is a side effect, which type, extent, or result of the summary of product characteristics is different.
(8) "regularly updated report on the safety of veterinary medicinal products (PSUR)" the report with the article is 75 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products OJ No. 311 of 11 p. 1, as last amended by Regulation (EC) No. 596/2009, OJ No. L 188 of July 18, 2009 p. 14, records referred to.
(9) "monitoring study after the traffic" is a pharmacoepidemiological study or a clinical trial in accordance with the terms of the approval, with the aim of establishing a safety hazard relating to an authorized veterinary medicinal and describe.
(10) "not proper use" is the use of a veterinary medicinal product contrary to the summary of the product characteristics, including the misuse and serious abuse.
(11) 'Waiting period' is the period that is between the last administration of a medicinal product to animals under compliance with drug law and the time to the these animals may be used for extracting food or medicinal products, which ensure that residues of the administered substances in these foods do not exceed the No. 470 / 2009 set maximum levels for pharmacologically active substances in accordance with Regulation (EC).
Reporting by health professionals
§ 3 reportable are doctors, dental surgeons/dentists, dentist/Dentistinnen, midwives, veterinary surgeons/veterinarians and if not the reporting obligation as a marketing authorisation holder subject to, pharmacy/pharmacists and producers who are entitled pursuant to the Gewerbeordnung 1994 to the manufacture of medicinal products or wholesale trade with pharmaceuticals, and druggist/chemists.
4. that the disclosure on the basis of their / its professional activity receives § information about 1. medicinal products with regard to suspected adverse reactions, or 2. veterinary medicinal products as regards a) suspected adverse reactions or b) suspected adverse reactions when people or c) used not normally or d) lack of expected efficacy, or e) insufficient waiting times have occurred domestically, so has to inform it the Federal Office for security in health care without delay.
Obligations of the holder of the approval of a human medicinal
§ 5. The obligations of the holder of the approval of a Humanarzneispezialtät in the §§ 75i are up to 75m of the medicines Act, BGBl. guidelines on good practice in the area of pharmacovigilance created no. 185/1983 in the current version, in conjunction with the European Commission regulated.
Obligations of the holder of the approval of a veterinary medicinal
Section 6 (1) of the holder of the authorisation has 1 suspected side effects in humans or 3rd which domestically are occurred in non-conformity using or 4. the lack of expected efficacy or 5 not adequate latency and note were brought to him, to capture and the Federal Office for security in healthcare suspected immediately, at the latest but within 15 days after becoming aware serious side effects or 2. , to report. The marketing authorisation holder has the original text which it filed related release to document and without delay deliver the Federal Office for security in the healthcare sector at the request.
(2) the marketing authorisation holder has also all suspected serious adverse reactions and side effects in humans, which occurred in Germany and meet the criteria for reporting in accordance with the Guide and of which he could have knowledge in expending the necessary care to capture and the Federal Office for security in health care immediately, at the latest within 15 days after the announcement, to sign.
(3) the holder of the authorisation has also side effects in humans, all suspected serious unexpected adverse reactions and any suspected transmission of infectious agents through the medicinal, not occurred in a Contracting Party to the agreement on the European economic area, immediately in accordance with the Guide, latest however within 15 days after the announcement, the Agency (§ 1 para 18 medicines Act, Federal Law Gazette No. 185/1983 in the currently valid version) and the Federal Office for security in healthcare report.
(4) in the case of medicinal products which have been approved within the framework of the decentralised or mutual recognition procedure pursuant to articles 31 and 32 of Directive 2001/82/EC or subject to an arbitration pursuant to articles 36, 37 and 38 of Directive 2001/82/EC were, provides the holder of the authorisation to additionally ensure that all suspected serious adverse reactions and side effects in humans, which occurred in the domestic , so be informed that this information is accessible to the reference Member State in the framework of its responsibility for the analysis and monitoring of such side effects.
/ The Pharmakovigilanzverantwortliche
Section 7 (1) the holder of the authorisation of a veterinary medicinal has permanently and continuously over a Pharmakovigilanzverantwortliche / a Pharmakovigilanzverantwortlichen, who is her / his seat in a Contracting Party to the agreement on the European economic area has to have. The marketing authorisation holder has the Pharmakovigilanzverantwortliche / the Pharmakovigilanzverantwortlichen with the necessary powers and resources to carry out the tasks referred to in paragraph 4 to equip.
(2) the holder of the authorisation shall inform with the order of Pharmakovigilanzverantwortlichen / the Pharmakovigilanzverantwortlichen referred to in paragraph 1 and any change in the same/same the Federal Office for security in healthcare.
(3) / the Pharmakovigilanzverantwortliche referred to in paragraph 1 must have in terms of their tasks the required expertise and experience in the entire field of pharmacovigilance. The expertise and experience are to prove through documentation. If it is not itself sufficient medically qualified, he must have access to a properly medically qualified person.
(4) the Pharmakovigilanzverantwortliche referred to in paragraph 1 has in particular 1 a system to set up and maintain, which ensure is that information about all suspected adverse reactions which are reported to the personnel of the pharmaceutical company, including its sales staff and its agents are collected and put together so that they are available in at least one place in the European economic area, 2 in § 6 of this regulation, as well as in § 75 b subsection 4 of the German medicines Act in the version before amendment to the Federal Law Gazette I no. 110/2012 referred Messages and reports to the competent authorities in this set form and in accordance with the Guide to create 3 to ensure that any request from the competent authorities on the provision of additional information for the evaluation of the benefits and risks of a medicinal product fully and promptly be answered, including the provision of information on the revenue, sales volume or prescriptions for the medicinal product concerned ,
the competent authorities of any further assessment of benefit and risk of a medicinal product, including information from safety studies after approval or monitoring studies according to the placing on the market, to teach, and 5 to ensure that the design and implementation of non - interventional studies in accordance with § 2a para 3 of the German medicines Act takes into account the reporting obligations in accordance with this regulation and respected.
Obligations of the holder of a registration of a pharmacy-own medicinal
§ 8 (1) the holder of a registration of a pharmacy-own medicinal has suspected serious adverse reactions which have occurred domestically and note were brought to him, to capture and the Federal Office for security in health care immediately, at the latest within 15 days after the announcement, to sign. The holder of the registration has the original text which it filed related release to document and without delay deliver the Federal Office for security in the healthcare sector at the request.
(2) the holder of a registration of a pharmacy own medicinal has suspected non-serious side effects that have occurred in Germany and note were brought to him, to collect and report the Federal Office for security in health care within 90 days after the announcement. The holder of the registration has the original text which it filed related release to document and without delay deliver the Federal Office for security in the healthcare sector at the request.
Form of reports
Messages section 9 (1) under this regulation are basically electronically to submit on the home page of the Federal Office for security in healthcare. A transmission by electronic means is not possible, the messages by means of the forms referred to in paragraph 4 must be communicated. Messages through authorisation of veterinary medicinal products or holder of a registration of a pharmacy-own medicinal have correspond to the generally accepted scientific principles.
(2) messages through disclosure in accordance with § 3 are to submit electronically via the home page of the Federal Office for security in healthcare or by means of the forms referred to in paragraph 3 in accordance with the technical possibilities.
(3) the forms for messages through disclosure in accordance with § 3 are to publish by the Federal Office for security in health care on its Web site.
(4) the forms for messages through authorisation of veterinary medicinal products or holder of a registration of a pharmacy-own medicinal are to publish by the Federal Office for security in health care on its Web site. For individual messages also a logon form can be in place of the form "Corporate message" of the "Council for International Organisations of Medical sciences" (CIOMS) be used.
(5) a message electronically is not possible and the forms referred to in paragraph 3 and 4 shall not be available, is the message first informally to undertake. The electronic message, the form or the form of the CIOMS is first to deliver the Federal Office for security in healthcare
§ 10. If on the basis of the facts to be reported in accordance with this regulation a direct danger to life or serious and substantial danger to health is to get an instant message to the Federal Office for security in the health care sector must be by phone in addition to the electronic or written message.
Referring to acts of the European Union
§ 11. Through this regulation, following directives of the European Union are implemented: 1. Directive 2001/82/EC;
2. Directive 2004/28/EC amending Directive 2001/82/EC establishing a Community code relating to veterinary medicinal products OJ No. L 136, 30 04 2004 p. 58.
Entry into force
§ 12. With entry into force of this regulation, the regulation concerning Pharmakovigilanzanforderungen and Pharmakovigilanzmeldungen occurs 2006 (pharmacovigilance Regulation 2006 - PhVO 2006), Federal Law Gazette II No. 472/2005 amended regulation BGBl. II No. 40/2009, except for force.
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