Pharmacovigilance Regulation 2006

Original Language Title: Pharmakovigilanz-Verordnung 2006

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Get a Day Pass for only USD$9.99.
472. Regulation of the Federal Minister for health and women regarding Pharmakovigilanzanforderungen and Pharmakovigilanzmeldungen (pharmacovigilance Regulation 2006 - PhVO 2006)

On the basis of the sections 75a para 4 and 75 (b) paragraph 8 and 9 of the medicines Act, Federal Law Gazette No. 185/1983, as last amended by Federal Law Gazette I no. 153/2005, is prescribed:

Scope



§ 1. This regulation applies to



1 drug in traffic, 2. medicinal products approved and registered traditional herbal medicinal, and 3. the components.

Definitions



2. (1) is "Guide" created by the European Commission and published in volume 9 of the rules of the medicinal products of the European Community guidelines on the collection, verification and presentation of adverse reaction reports, including technical requirements for electronic exchange of pharmacovigilance information in accordance with internationally agreed formats.

(2) "Pharmakovigilanzverantwortliche/Pharmakovigilanzverantwortlicher" is a person responsible for pharmacovigilance and qualified in accordance with section 10 subsection 3.

Human medicines



3. (1) 'Adverse reaction' is a response to the medicinal product which is noxious and unintended and that occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function.

(2) "Serious adverse reaction" is a side-effect, which is fatal or life-threatening, requires inpatient treatment or extension of inpatient treatment to permanent or fatal disability or disability leads, or is a congenital anomaly or a birth defect.

(3) "Unexpected adverse reaction" is a side effect, which type, extent, or result of the summary of product characteristics is different.

(4) "regularly updated report on the safety of medicinal products (PSUR)" the report with the article is 104 of Directive 2001/83/EC, as amended by directives 2004/24/EC and 2004/27/EC, records referred to.

(5) "Safety study after admission" is a pharmacoepidemiological study or a clinical trial in accordance with the stipulations of the approval with the aim of establishing a safety hazard relating to an authorised medicinal or quantitatively describing.

(6) "Abuse of a medicinal product" is the intended permanent or sporadic excessive use of a pharmaceutical product with physical or mental damage as a result.

(7) "Serious misuse of a drug" is the intended permanent or sporadic excessive use of a medicinal product, which is fatal or life threatening, does require a hospitalization or extension of inpatient treatment, leads to permanent or fatal disability or incapacity or cause a congenital anomaly or birth defect.

(8) are "Lack of quality"



1 is to get defects within the meaning of section 4 of the medicines Act and 2. shortcomings of marketed medicinal trade packs, composition or texture, making a threat to life or health of people.

Veterinary medicinal products



4. (1) 'Adverse reaction' is a response to the medicinal product which is noxious and unintended and that occurs at doses normally used in animals for the prophylaxis, diagnosis or therapy of disease or the modification of physiological function.

(2) 'Adverse reaction in humans' is a reaction which is noxious and unintended and occurs in humans following exposure to a veterinary medicinal product.

(3) "Serious adverse reaction" is a side-effect, 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.

(4) "Unexpected adverse reaction" means an adverse reaction, which type, extent, or result of the summary of product characteristics is different.

(5) "regularly updated report on the safety of veterinary medicinal products (PSUR)" the report with the article is 75 of Directive 2001/82/EC, as amended by Directive 2004/28/EC, records referred to.

(6) "Monitoring study for the marketing" is a pharmacoepidemiological study or clinical trial in accordance with the terms of the approval, with the aim of establishing a health risk associated with an approved veterinary medicinal and describe.

(7) "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.

(8) 'Waiting period' is the period after the last administration of a medicinal product to animals under compliance with drug law and the time, to which these animals must be used to obtain medicines or foods, to comply, and which ensure that residues of the administered substances in these foods No. cannot exceed 2377/90 laid down maximum levels for pharmacologically active substances in accordance with Council Regulation (EEC).

(9) are "Lack of quality"



1 is to get defects within the meaning of section 4 of the medicines Act and 2. shortcomings of marketed medicinal trade packs, composition or texture, making a threat to life or health of humans or animals.

Messages



§ 5 subject doctors, dental surgeons/dentists, dentist/Dentistinnen, veterinarians/veterinarians, midwives, and as far as they are subject to not the notification as a marketing authorisation holder or holder of the registration as traditional herbal medicinal pursuant to §§ 8 or 9 or as a holder of an authorisation for distribution in the parallel import in accordance with § 11, pharmacy/pharmacists and traders authorized pursuant to the Gewerbeordnung 1994 to the manufacture of medicinal products or wholesale trade in medicinal products are , and druggist/chemists.

Messages to medicinal



§ 6 that the disclosure on the basis of their / its professional activity will receive information on medicinal products for human with regard to



1 suspected serious adverse reactions, or 2. frequently observed misuse or serious abuse 3, or 4. quality defects which have occurred domestically, so has to inform it immediately in the Federal Office for security in healthcare.

Messages veterinary medicinal



§ 7 / of the disclosure on the basis of their / its professional activity receives information about medicinal products with regard to



1 suspected serious adverse reactions, or 2. suspected adverse reactions in humans, or 3 not proper usage, 4. lack of expected efficacy, or 5th not sufficient waiting time, or 6 quality defects which have occurred domestically, so has to inform it immediately in the Federal Office for security in healthcare.

Obligations of the marketing authorisation holder and the holder of a registration as traditional herbal medicinal

Human medicines



Section 8 (1) the holder of the authorisation of a medicinal has



1 suspected serious side effects, or 2. frequently observed misuse or serious abuse, or 3. quality defects, which occurred in Germany and by a a member of a health profession noted were brought to him, to capture and the Federal Office for security in health care immediately, at the latest but within 15 days after the announcement, to sign. This message has the original wording of the holder of the authorisation filed to include related communication.

(2) the holder of the authorisation of a medicinal also has all suspected serious adverse reactions that have occurred in the domestic and the criteria could comply with reporting in accordance with the Guide for the and of which he 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 authorisation of a medicinal has also to ensure that all suspected serious unexpected adverse reactions and any suspected transmission of pathogens by the medicinal, not in a Contracting Party to the European economic area have occurred, immediately in accordance with the Guide, at the latest however within 15 days after the announcement, the European Medicines Agency and communicated to the Federal Office for security in healthcare.


(4) in the case of medicinal products which have been approved within the framework of the decentralised or mutual recognition procedure in accordance with articles 28 and 29 of Directive 2001/83/EC, as amended by directives 2004/24/EC and 2004/27/EC, or the subject of an arbitration in accordance with articles 32, 33 and 34 of Directive 2001/83/EC, as amended by directives 2004/24/EC and 2004/27/EC , were, provides the holder of the authorisation to additionally ensure that all suspected serious adverse reactions which have occurred domestically, be communicated 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.

(5) paragraphs 1 to 4 shall apply by analogy to the holder of the registration as traditional herbal medicinal.

Veterinary medicinal products



§ 9 (1) the holder of the authorisation of a medicinal has



1. suspected serious side effects or suspected adverse reactions in humans, or 2. the use of non-conformity, or 3. the lack of expected efficacy, or 4 not sufficient waiting time, or 5. quality defects, which occurred in Germany and noted, brought him to capture and the Federal Office for security in health care immediately, but within 15 days after the announcement, to sign. This message has the original wording of the holder of the authorisation filed to include related communication.

(2) the authorisation of a medicinal 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 authorisation of a medicinal shall also ensure that side effects in humans, all suspected serious unexpected adverse reactions and any suspected transmission of pathogens by the medicinal, not in a Contracting Party to the European economic area have occurred, immediately in accordance with the Guide, at the latest however within 15 days after the announcement, the European Medicines Agency and communicated to the Federal Office for security in healthcare.

(4) in the case of medicinal products, which under decentralised or mutual recognition procedure pursuant to articles 31 and 32 of Directive 2001/82/EC, as amended by Directive 2004/28/EC, have been approved, or were the subject of an arbitration in accordance with articles 36, 37 and 38 of Directive 2001/82/EC, as amended by Directive 2004/28/EC, the authorisation-holder provides in addition that , that all suspected serious adverse reactions and side effects in humans, that have occurred in the country, as communicated, 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



§ 10 (1) the holder of the authorisation of a medicinal has permanently and continuously over a Pharmakovigilanzverantwortliche / a Pharmakovigilanzverantwortlichen, who has her / his seat in a Contracting Party to the European economic area, to have. The holder of the authorisation of a medicine specialty 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 order of Pharmakovigilanzverantwortlichen / the Pharmakovigilanzverantwortlichen and any change in the same/same is inform the Federal Office for security in the health care sector by the holder of the authorisation.

(3) / the Pharmakovigilanzverantwortliche 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) that the Pharmakovigilanzverantwortliche has in particular



1. a system to set up and run, with the ensured 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 paragraphs 8 and 9, as well as in § 75 b subsection 4 of the German medicines Act notifications referred to and reports to the competent authorities in this set form and in accordance with the Guide be 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 is answered fully and promptly, including the provision of information on the revenue, sales volume or prescriptions for the medicinal product concerned, 4. the competent authorities about any further assessment of benefit and risk of a medicinal product, including information on post-authorisation safety studies after approval or monitoring studies according to the placing , teach, and 5 to ensure that the reporting obligations pursuant to this regulation are taken into account and complied in the design and implementation of application studies in accordance with § 2a para 3 of the medicines Act.

(5) paragraphs 1 to 4 apply by analogy to the holder of the registration as traditional herbal medicinal.

Obligations of the holder of a permit for the distribution in the parallel import



§ 11 for distribution in the parallel import (for medicinal products by a member of a member of a health profession) receives marketing authorisation holders information about



1 suspected adverse reactions in humans related to the use of veterinary medicinal products, suspected serious side effects of medicinal products, or 2. suspected serious adverse reactions or serious abuse of medicinal products for human use, or 3 frequently observed misuse or 4 not proper use of veterinary medicinal products, or 5 the lack of expected efficacy of veterinary medicinal products, or 6 not sufficient waiting time in connection with the use of veterinary medicinal , or quality defects of human and veterinary medicinal products that have occurred in Germany, he has 7 to capture them and the Office of safety and health without delay, at the latest within 15 days after the announcement, to sign. This message has the original wording of the holder of a permit for the distribution in the parallel import filed to include related communication. Also has an authorisation of distribution in the parallel import holder within the period to inform the marketing authorisation holder or the holder of the registration as traditional herbal medicinal about this message.

Form of reports



Notifications under articles 8, 9 and 11 are § 12 (1) exceptional circumstances other than electronically. 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 medicinal products, by the holder of the registration as traditional herbal medicinal or by the holder of an authorisation for distribution in the parallel import must comply with the generally accepted scientific principles and requirements laid down in the guidelines.

(2) messages through disclosure in accordance with § 5 are in accordance with the technical capabilities to send electronically or by means of the registration cards referred to in paragraph 3. Electronic messages have the reporter to contain the secure electronic signature

(3) the registration cards for messages through disclosure in accordance with § 5 are imposed at the Federal Office for security in the health care sector and can be obtained there.

(4) the forms for messages through authorisation of medicinal products, by the holder of the registration as traditional herbal medicinal or by the holder of an authorisation for distribution in the parallel import are available at a location to be designated by the Federal Office for security in health care against a possible reimbursement. These reports must be submitted in duplicate. For individual messages from a third country may also a registration form in place of the form "Corporate message" of the "Council for International Organisations of Medical sciences" (CIOMS) be used.

(5) a notification by electronic means is not possible, and in paragraph 3 and 4 above forms or registration cards are not available, is the message first informally to undertake. The electronic message, the form or the completed registration card is first to deliver the Federal Office for security in healthcare.

Instant message




§ 13. 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.

Transitional provisions regarding PSUR template



Section 14 (1) for medicinal products which I no. 153/2005 were admitted five years ago in force of the German medicines Act in the version of Federal Law Gazette, I apply the PSUR template the deadlines pursuant to § 75a para 4 medicines Act in the version prior to in force of the Federal Act Federal Law Gazette No. 153/2005 until the expiry of five years reckoned from the date of approval. At that time, the PSUR template at intervals of three years has to be carried out.

(2) for medicinal products, which prior to in force of the German medicines Act in the version of Federal Law Gazette I no. 153/2005 were admitted and the existence of the prerequisites already in accordance with section 19a of the medicines Act in the version prior to in force of the Federal Act Federal Law Gazette I no. 153/2005 has been demonstrated, has the PSUR template within three years of the in force of the German medicines Act in the version of Federal Law Gazette I no. 153 / 2005 in consultation with the Federal Office for security in healthcare. At that time, the PSUR template at intervals of three years has to be carried out.

(3) for the medicinal products referred to in article 94a par. 2 of the medicines Act, the PSUR template from the date of the application is submitted in accordance with section 94 c paragraph 11 has medicines Act in the version of Federal Law Gazette I no. 153/2005 at intervals of three years to be carried out.

Referring to acts of the European Community



§ 15. The following European Community directives are implemented by this Regulation:



1 Directive 2001/82/EC establishing a Community code relating to veterinary medicinal products OJ No. L 311 of 28 November 2001;

2. Directive 2001/83/EC establishing a Community code relating to medicinal products, OJ No. L 311 of 28 November 2001;

3. Directive 2004/24/EC amending the Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards traditional herbal medicinal products, OJ No. L 136, 30 April 2004;

4. Directive 2004/27/EC amending Directive 2001/83/EC establishing a Community code relating to medicinal products, OJ No. L 136, 30 April 2004;

5. Directive 2004/28/EC amending Directive 2001/82/EC establishing a Community code relating to veterinary medicinal products OJ No. L 136, 30 April 2004.

In force



§ 16. This Regulation shall enter into force January 2, 2006. In force of this regulation is the regulation on the notification of adverse drug reactions (reporting regulation), Federal Law Gazette II No. 457/2002, override.

Rauch-Kallat

Related Laws