472. Federal Minister for Health and Women's Regulation on pharmacovigilance and pharmacovigilance (Pharmacovigilance-Regulation 2006-PhVO 2006)

Due to § § 75a (4) and 75b (8) and (9) of the German Medicines Act, BGBl. No 185/1983, as last amended by BGBl. I No 153/2005, shall be ordered:

Scope

§ 1. This Regulation shall apply to:

1.		medicines placed on the market,
2.		authorized proprietary medicinal products and registered traditional herbal medicinal products; and
3.		whose components.

Definitions

§ 2. (1) 'Guide' is the guide to the collection, review and presentation of adverse reactions reports drawn up by the European Commission and published in Volume 9 of the European Community Medicines Regulation; , including the technical requirements for the electronic exchange of pharmacovigilance data in accordance with internationally agreed formats.

(2) "Pharmacovigilance responsible/pharmacovigilance officer" shall be a person responsible for the supervision of medicinal products and qualified in accordance with § 10 (3).

Medicinal products for human use

§ 3. ( 1 ) "side effect" means a reaction to the medicinal product which is harmful and unintended and which occurs at doses such as those normally used in humans for the prophylaxis, diagnosis or treatment of diseases or for recovery, correction or change of a physiological function.

(2) "serious adverse reaction" means a side effect which is fatal or life-threatening, requires hospitalisation or extension of a stationary treatment, is a permanent or serious disability or disability or invalidity or a congenital anomaly or is a birth defect.

(3) "Unexpected side effect" is a side effect, the nature, extent or result of which differs from the summary of product characteristics.

(4) 'Periodically updated report on the safety of medicinal products (PSUR)' is the report with the records referred to in Article 104 of Directive 2001/83/EC, as amended by Directives 2004 /24/EC and 2004 /27/EC.

(5) 'post-authorisation safety study' means a pharmacoepidemiological study or clinical trial in accordance with the terms of the authorisation with the aim of determining a health risk associated with an authorised medicinal product; or quantitatively.

(6) "abuse of a medicinal product" means the intended permanent or sporadic use of a medicinal product with physical or psychological damage as a consequence.

(7) 'Serious Abuse of a medicinal product' means the intended permanent or sporadic use of a medicinal product which is fatal or life-threatening, a steady-state treatment or an extension of a steady-state treatment. is required to lead to permanent or serious disability or invalidity, or to a congenital anomaly, caused a birth defect.

(8) "quality defects"

1.		Defects within the meaning of Section 4 of the Medicines Act and
2.		defects of a medicinal product placed on the market with regard to commercial packaging, composition or composition;
if it is to endanger the life or health of people.

Veterinary medicinal products

§ 4. (1) 'adverse reaction' means a reaction to the medicinal product which is harmful and unintended and which occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of diseases or for the modification of a medicinal product; physiologic function.

(2) "adverse reaction in humans" means a reaction which is harmful and unintentional and occurs in humans after exposure to a veterinary medicinal product.

(3) "serious adverse reaction" means a side effect which is fatal or life-threatening, leads to significant disability or invalidity, congenital anomalies or Birth defects caused by the following generation, or that occurring in the treated animals, or The symptoms are long-lasting symptoms.

(4) "Unexpected side effect" is a side effect, the nature, extent or result of which differs from the summary of product characteristics.

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

(6) 'post-marketing surveillance study' means a pharmacoepidemiological study or clinical trial, in accordance with the terms of the authorisation, with the aim of a health hazard associated with an authorised veterinary medicinal product; to identify and describe.

(7) "Non-compliant use" means the use of a veterinary medicinal product, contrary to the information on the summary of product characteristics, including improper use or serious abuse.

(8) "waiting period" means the period of time after the last administration of a medicinal product to animals in compliance with medicinal product legislation and the date on which such animals are used for the production of medicinal products or foodstuffs; , and which ensures that residues of the substances administered in these foods shall be subject to the maximum residue limits of pharmacologically active substances laid down in Regulation (EEC) No 2377/90 do not exceed.

(9) "quality defects"

1.		Defects within the meaning of Section 4 of the Medicines Act and
2.		defects of a medicinal product placed on the market with regard to commercial packaging, composition or composition;
if it is to cause a risk to life or health of humans or animals.

Notifications

§ 5. Doctors, Dentists, Dentists, Veterinary Surgeons, Midwives, and insofar as they do not have the obligation to notify as a marketing authorisation holder or as holders of a registration as a traditional herbal medicinal product, the following must be reported. Pursuant to § § 8 or 9 or as holders of a marketing authorisation for parallel import in accordance with § 11, pharmacists/pharmacists and tradesmen who, according to the 1994 Commercial Code, are subject to the manufacture of medicinal products or to the Wholesale trade with medicinal products is justified, and drogists/drogistinnen.

Medicinal products for human use

§ 6. If the notifiable person (s) receives information on medicinal products for human use on the basis of his/her professional activity,

1.		suspected serious adverse reactions, or
2.		frequently observed improper use, or
3.		serious abuse, or
4.		Quality defects,
The Federal Office for Health and Safety (Bundesamt für Sicherheit im Healthcare) has to inform the Federal Office for Safety of Health without delay.

Veterinary medicinal products

§ 7. If the notifiable person (s) receives information on veterinary medicinal products by reason of his/her professional activity,

1.		suspected serious adverse reactions, or
2.		suspected adverse reactions in humans, or
3.		non-compliant use, or
4.		Failure to expect the expected efficacy, or
5.		insufficient waiting time, or
6.		Quality defects,

The Federal Office for Health and Safety (Bundesamt für Sicherheit im Healthcare) has to inform the Federal Office for Safety of Health without delay.

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

Medicinal products for human use

§ 8. (1) The marketing authorisation holder of a proprietary medicinal product shall have:

1.		suspected serious adverse reactions, or
2.		frequently observed improper use or serious abuse, or
3.		Quality defects,
which have occurred in the country and have been brought to the attention of one of a health-care professional by one of the members of the health-care profession, and the Federal Office for Health and Safety in the healthcare sector without delay, but no later than 15 days after the date of the Notice, report. This notification shall include the original wording of the notice given to the authorisation holder.

(2) The marketing authorisation holder of a proprietary medicinal product also has all suspected serious adverse reactions which have occurred in the country and which correspond to the criteria for reporting in accordance with the guidelines and of which he/she is responsible for the application of the , the Federal Office for Health and Safety (Bundesamt für Sicherheit im Healthcare) was able to report without delay and at the latest within 15 days of becoming aware of the information.

(3) The marketing authorisation holder of a proprietary medicinal product shall also ensure that all suspected serious unexpected adverse reactions and any suspected transmission of pathogens by the medicinal product, which are not in a contracting party the European Medicines Agency and the European Medicines Agency and the Federal Office for Health and Safety shall be notified without delay and at the latest within 15 days of the date of the publication of the Guide.

(4) In the case of proprietary medicinal products authorised under 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 In accordance with Articles 32, 33 and 34 of Directive 2001/83/EC, as amended by Directives 2004 /24/EC and 2004 /27/EC, the authorisation holder shall also ensure that all suspected serious cases are subject to arbitration. Adverse reactions that have occurred in the country are reported in such a way as to ensure that this information is provided. shall be accessible to the reference Member State in the context of its responsibility for the analysis and monitoring of such adverse reactions.

(5) The provisions of paragraphs 1 to 4 shall also apply to the holder of a registration as a traditional herbal medicinal product.

Veterinary medicinal products

§ 9. (1) The marketing authorisation holder of a proprietary medicinal product shall have:

1.		suspected serious adverse reactions or suspected adverse reactions in humans, or
2.		the non-compliant use, or
3.		the failure to make the expected efficacy, or
4.		insufficient waiting time, or
5.		Quality defects,
to report and report to the Federal Office for Health Security without delay and no later than 15 days after the notification has been made to the Federal Office for Health. This notification shall include the original wording of the notice given to the authorisation holder.

(2) The marketing authorisation holder of a proprietary medicinal product also has all suspected serious adverse reactions and adverse reactions to the person who have occurred in the country and meet the criteria for reporting in accordance with the guidelines and by which he was able to have knowledge of the due diligence and to report and report to the Federal Office for Health and Safety immediately, but no later than 15 days after the date of the notification.

(3) The marketing authorisation holder of a proprietary medicinal product shall also ensure that all suspected serious unexpected adverse reactions, adverse reactions in humans and any suspected transmission of pathogens by the medicinal product, which are: have not occurred in one of the Contracting Parties to the European Economic Area, without delay in accordance with the guidelines, but no later than 15 days after the date of the notification, the European Medicines Agency and the Federal Office for Security in the Health care.

(4) In the case of proprietary medicinal products authorised under the decentralised or mutual recognition procedure in accordance with Articles 31 and 32 of Directive 2001 /82/EC, as amended by Directive 2004 /28/EC, or the subject-matter of a Arbitration proceedings under Articles 36, 37 and 38 of Directive 2001/82/EC, as amended by Directive 2004 /28/EC, the marketing authorisation holder shall, in addition, ensure that all suspected serious adverse reactions and adverse reactions occur in the case of: People who have occurred domestily are told that this information shall be accessible to the reference Member State in the context of its responsibility for the analysis and monitoring of such adverse reactions.

The pharmacovigilance responsible

§ 10. (1) The marketing authorisation holder of a proprietary medicinal product shall be responsible for the continuous and continuous use of a pharmacovigilance officer (pharmacovigilance) responsible for his/her seat in a Contracting Party to the European Economic Area; shall be available. The marketing authorisation holder of a proprietary medicinal product shall provide the pharmacovigilance and pharmacovigilance authorities with the necessary powers and resources to carry out the tasks referred to in paragraph 4.

(2) The appointment of the pharmacovigilance and pharmacovigilance authorities and any modification of the same/same shall be notified without delay by the marketing authorisation holder to the Federal Office for Safety in the Health Care Sector.

(3) The pharmacovigilance officer shall have the necessary expertise and experience in the overall pharmacovigilance sector with a view to his/her tasks. The expertise and experience must be proven by documentation. If she/he is not sufficiently medically qualified, she/she must have access to a suitably medically qualified person.

(4) The pharmacovigilance officer/pharmacovigilance officer shall in particular:

1.		to establish and maintain a system to ensure that information on all suspected adverse reactions is reported to the staff of the pharmaceutical company, including its sales staff and its representatives, be collected and collated so that they are available in at least one location in the European Economic Area,
2.		to draw up the notifications and reports referred to in Articles 8 and 9 and in Section 75b (4) of the Medicines Act for the competent authorities in the form and in accordance with the guidelines laid down by that authority,
3.		ensure that all requests from the competent authorities to provide additional information for the assessment of the benefits and risks of a medicinal product are fully and rapidly answered, including the provision of information the volume of sales, sales or presenter for the medicinal product concerned,
4.		to inform the competent authorities of any further evaluation of the benefits and risks of a medicinal product, including information on post-marketing safety studies or post-marketing surveillance studies, and
5.		ensure that the reporting obligations laid down in this Regulation are taken into account and complied with in the design and implementation of application observations pursuant to Section 2a (3) of the Medicines Act.

(5) Para. 1 to 4 shall also apply to the holder of a registration as a traditional herbal proprietary medicinal product.

Obligations of the holder of a marketing authorisation in parallel import

§ 11. If the holder of a marketing authorisation receives information on the parallel import (in the case of medicinal products for human use by a member of a health professional), information on:

1.		suspected serious adverse reactions to medicinal products for human use, or
2.		suspected serious adverse reactions or suspected adverse reactions in humans in connection with the use of veterinary medicinal products, or
3.		frequently observed improper use or serious misuse of medicinal products for human use, or
4.		the non-compliant use of veterinary medicinal products; or
5.		the failure to ensure the expected efficacy of veterinary medicinal products; or
6.		insufficient waiting time in connection with the use of veterinary medicinal products, or
7.		the quality defects of medicinal products for human and veterinary use,
The Federal Office for Safety and Health shall report it and report it to the Federal Office for Safety and Health without delay, but no later than 15 days after the date of the notification. This notification shall contain the original wording of the notice issued to the holder of a marketing authorisation for the parallel import. In addition, the holder of a parallel import marketing authorisation has to inform the marketing authorisation holder or the holder of a registration as a traditional herbal medicinal product of this notification within the time limit.

Form of notifications

§ 12. (1) Notifications in accordance with § § 8, 9 and 11 shall be transmitted electronically, except in exceptional cases. Where a transmission is not possible by electronic means, the notifications shall be transmitted by means of the forms referred to in paragraph 4. Notifications by marketing authorisation holders of proprietary medicinal products, by holders of a registration as a traditional herbal medicinal product or by holders of a marketing authorisation for parallel import shall have the generally accepted to comply with scientific principles and requirements in accordance with the guidelines.

(2) Notifications by notifiers according to § 5 shall be transmitted electronically or by means of the notification cards referred to in paragraph 3, in accordance with the technical possibilities. Electronic messages shall contain the secure electronic signature of the reporting person

(3) The notification cards for reporting by persons subject to notification in accordance with § 5 shall be published by the Federal Office for Safety in the Health Care and can be obtained there.

(4) The forms for notifications by marketing authorisation holders of proprietary medicinal products, by holders of a registration as a traditional herbal medicinal product or by holders of a marketing authorisation for parallel import shall be the case with one of the following: The Federal Office for Health and Safety in the Public Health Service (Bundesamt für Sicherheit im Healthcare) is available for sale against any cost replacement. These notifications must be submitted in two copies. For individual case reports from a third country, a registration form of the "Council for International Organisations of Medical Sciences" (CIOMS) can also be used instead of the form "Company notification".

(5) If a notification is not possible by electronic means and the forms or registration cards referred to in paragraphs 3 and 4 are not available, the notification shall initially be made informally. The electronic message, the filled-out form or the completed registration card must be sent to the Federal Office for Health and Safety at the Federal Office for Health at the time of the event.

Immediate message

§ 13. If, on the basis of the facts to be reported in accordance with this Regulation, a direct threat to life or serious and serious health hazards is to be provided, an immediate, electronic or written notification shall be required Notification to the Federal Office for Safety in the Health Care Service by telephone.

Transitional arrangements concerning PSURs

§ 14. (1) For proprietary medicinal products within five years prior to the entry into force of the Medicines Act, as amended by the Federal Law BGBl. In accordance with Section 75a (4) of the German Medicines Act (PSUR), the time limits for the PSUR submission shall apply in the version before the entry into force of the Federal Law BGBl. I n ° 153/2005 up to the expiry of five years from the date of authorisation. From this point on, the PSUR submission must be made at intervals of three years.

(2) For proprietary medicinal products, which are before the entry into force of the Medicines Act, as amended by the Federal Law BGBl. In accordance with § 19a of the German Medicines Act (Bundesgesetz, Federal Law Gazette), the German Federal Law on Drugs and Drug Law (BGBl) has already been approved in accordance with § 19a of the German Medicines Act (pharmaceutical Act). I n ° 153/2005, the PSUR submission has been submitted within three years from the entry into force of the German Medicines Act, as amended by the Federal Law BGBl. I n ° 153/2005, in agreement with the Federal Office for Health Security. From this point on, the PSUR submission must be made at intervals of three years.

(3) For the proprietary medicinal products referred to in § 94a (2) of the German Medicines Act, the PSUR submission shall be replaced by the Federal Law BGBl (Bundesgesetz BGBl) from the date on which the application was submitted in accordance with Section 94c (11) of the Medicines Act. I No 153/2005, at intervals of three years.

References to acts of the European Community

§ 15. This Regulation implements the following directives of the European Community:

1.		Directive 2001 /82/EC establishing a Community code relating to veterinary medicinal products, OJ L 327, 31.12.2001, p. No. OJ L 311, 28 November 2001;
2.		Directive 2001 /83/EC establishing a Community code relating to medicinal products for human use, OJ L 327, 30.4.2001, p No. OJ L 311, 28 November 2001;
3.		Directive 2004 /24/EC amending Directive 2001 /83/EC on the Community code relating to medicinal products for human use as regards traditional herbal medicinal products, OJ L 327, 30.4.2004, p. No. L 136 of 30 April 2004;
4.		Directive 2004 /27/EC amending Directive 2001 /83/EC on the Community code relating to medicinal products for human use, OJ L 327, 30.4.2004, p. No. L 136 of 30 April 2004;
5.		Directive 2004 /28/EC amending Directive 2001 /82/EC establishing a Community code relating to veterinary medicinal products, OJ L 327, 30.4.2004, p. No. L 136 of 30 April 2004.

In-force pedals

§ 16. This Regulation shall enter into force on 2 January 2006. With the entry into force of this Regulation, the Regulation on the reporting of adverse drug effects (Reporting Ordinance), BGBl. II No 457/2002, except for force.

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