Pharmacovigilance Regulation 2013 - 2013 Phvo

Original Language Title: Pharmakovigilanz-Verordnung 2013 - PhVO 2013

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299. Regulation of the Federal Minister for Health on Pharmacovigilance Requirements and Pharmacovigilance (Pharmacovigilance-Regulation 2013-PhVO 2013)

On the basis of § § 75a, 75g Abs.1 as well as § 94h (7) and (8) of the Medicines Act, BGBl. No. 185/1983, as last amended by the Federal Law BGBl. I No 48/2013, shall be arranged:

Scope

§ 1. This Regulation shall apply in accordance with the following provisions:

1.

human and veterinary medicinal products placed on the market,

2.

authorised medicinal products for human and veterinary use,

3.

registered traditional herbal medicinal products,

4.

Registered pharmacist's own proprietary medicinal products and

5.

whose components.

Definitions

§ 2. (1) 'Guide' shall mean the pharmacovigilance guide on veterinary medicinal products produced by the European Commission and published in Volume 9b of the Regulation on medicinal products of the European Union.

(2) "Pharmacovigilance/pharmacovigilance officer" shall be a person responsible for the supervision of medicinal products and qualified in accordance with § 7.

(3) 'adverse reaction of a medicinal product for human use' shall be a harmful and unintended response to the medicinal product.

(4) 'side effect of a veterinary medicinal product' is a harmful and unintended reaction to the medicinal product which occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of diseases or for the modification of the medicinal product. of a physiological function.

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

(6) "serious adverse reaction to a veterinary medicinal product" 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.

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

(8) 'Regular update of the report on the safety of veterinary medicinal products (PSUR)' is the report of the report as set out in Article 75 of Directive 2001 /82/EC on the Community code relating to veterinary medicinal products, OJ L 327, 30.4.2001, p. OJ No 311 of 28.11.2011 p. 1, as last amended by Regulation (EC) No 596/2009, OJ L 311, 28.11.2009, p. No. OJ L 188, 18.07.2009 p. 14, notes.

(9) 'monitoring study after placing on the market' 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 speciality to identify and describe.

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

(11) 'waiting period' shall mean the period between the last administration of a medicinal product to animals in compliance with medicinal products and the date on which these animals are used for the production of foodstuffs or medicinal products; , and which ensures that residues of the substances administered in these foodstuffs are subject to the maximum permitted levels of pharmacologically active substances as laid down in Regulation (EC) No 470/2009 do not exceed.

Reporting requirements for health professionals

§ 3. Doctors, Dentists, Dentists, Midwives, Veterinary Surgeons and, in so far as they are not subject to the notification obligation, are subject to reporting requirements, pharmacists/pharmacists and tradesmen, who are subject to the requirements of the Industrial order 1994 for the manufacture of medicinal products or for wholesale of medicinal products are authorized, and Drogisten/Drogistinnen.

§ 4. If the notifiable person receives information on the basis of his/her professional activity,

1.

Medicinal products for human use with regard to suspected adverse reactions, or

2.

Veterinary medicinal products

a)

suspected serious adverse reactions, or

b)

suspected adverse reactions in humans or

c)

not properly used or

d)

Failure to expect the expected efficacy, or

e)

insufficient waiting time

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 of a medicinal product for human use

§ 5. The obligations of the marketing authorisation holder of a medicinal product for human use are in the § § 75i to 75m of the German Medicines Act, BGBl. No 185/1983, as amended, in conjunction with the guidelines on good practice in the field of pharmacovigilance, drawn up by the European Commission.

Obligations of the marketing authorisation holder of a veterinary speciality

§ 6. (1) The marketing authorisation holder shall:

1.

suspected serious adverse reactions, or

2.

suspected adverse reactions in humans or

3.

the non-compliant use or

4.

the failure to make the expected efficacy or

5.

insufficient waiting time

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. The marketing authorisation holder must document the original wording of the relevant communication in this respect and shall forward it without delay to the Federal Office for Health and Safety in the health sector.

(2) The marketing authorisation holder shall also have all suspected serious adverse reactions and adverse reactions to the person who has occurred in the country and which meet the reporting criteria in accordance with the guidelines and of which he/she shall be responsible for: The Federal Office for Health and Safety (Bundesamt für Sicherheit im Healthcare) was able to report and report to the Federal Office for Health and Safety without delay, but no later than 15 days after becoming aware of the information.

(3) The marketing authorisation holder shall also have all suspected serious unexpected adverse reactions, human side effects and any suspected transmission of pathogens by the medicinal product not in one of the contracting parties to the agreement. on the European Economic Area, in accordance with the guidelines, without delay, but no later than 15 days after the date of the notification, the Agency (Section 1 (18) of the Medicinal Products Act, BGBl. No. 185/1983 in the version in force) and the Federal Office for Safety in Health.

(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 or the subject-matter of an arbitration procedure provided for in Articles 36, 37 and 38 of Directive 2001 /82/EC, the marketing authorisation holder shall also ensure that all suspected serious adverse reactions and adverse reactions to the person who have occurred in the country are notified in such a way as to ensure that such information is communicated to the Reference Member State as part of its responsibility for the analysis and Surveillance of such side effects is available.

The pharmacovigilance responsible

§ 7. The marketing authorisation holder of a veterinary 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 Agreement on European The Economic Area has to have. The marketing authorisation holder shall provide pharmacovigilance and pharmacovigilance officers with the necessary powers and resources to carry out the tasks referred to in paragraph 4.

(2) The marketing authorisation holder shall immediately inform the Federal Office for Safety in the Health Care of the order of pharmacovigilance and pharmacovigilance officers as referred to in paragraph 1 above and any modification of the same/same.

The pharmacovigilance system referred to in paragraph 1 shall have the necessary expertise and experience in the whole area of pharmacovigilance with regard to its/its 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 referred to in paragraph 1 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.

§ 6 of this Regulation as well as § 75b (4) of the German Medicines Act (Medicines Act) in the version before the Novelle BGBl. I No 110/2012, to draw up reports and reports for the competent authorities in the form and in accordance with the guidelines laid down by the competent authorities,

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 from post-marketing safety studies or post-marketing surveillance studies, and

5.

ensure that, when designing and carrying out non-interventional studies pursuant to Section 2a (3) of the Medicines Act, reporting obligations are taken into account and complied with in accordance with this Regulation.

Obligations of the holder of a registration of an apothecary proprietary medicinal product

§ 8. (1) The holder of a registration of a pharmacist's own proprietary medicinal product has suspected serious adverse reactions which have occurred in the country and have been brought to the attention of him and the Federal Office for Security in the Health care should be reported immediately, but no later than 15 days after the notification has been made. The holder of the registration must document the original wording of the notice in this respect and submit it immediately to the Federal Office for Health and Safety in the health care sector upon request.

(2) The holder of a registration of a proprietary medicinal product has suspected non-serious adverse reactions which have occurred in the country and have been brought to the attention of the Federal Office for Safety and Security in the Health care within 90 days of becoming aware of the information. The holder of the registration must document the original wording of the notice in this respect and submit it immediately to the Federal Office for Health and Safety in the health care sector upon request.

Form of notifications

§ 9. (1) Notifications pursuant to this Regulation shall in principle be transmitted electronically via the Home Page of the Federal Office for Safety in Health Care. 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 veterinary medicinal products, or Holders of a registration of an apothectic proprietary medicinal product must comply with the generally accepted scientific principles.

(2) Notifications by notifiers according to § 3 shall be transmitted electronically via the home page of the Federal Office for Health Security or by means of the forms referred to in paragraph 3, in accordance with the technical possibilities.

(3) The forms for reporting by notifiers according to § 3 are to be published by the Federal Office for Health Security on the website of the Federal Office for Health and Safety.

(4) The forms for notifications by marketing authorisation holders of veterinary medicinal products. The Bundesamt für Sicherheit im healthcare (Federal Office for Health and Safety) is responsible for the publication of a registration of a pharmacist's proprietary medicinal product on its website. For individual case reports, 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 referred to in paragraphs 3 and 4 are not available, the notification shall first be made informally. The electronic message, the completed form or the registration form of the CIOMS is to be forwarded to the Federal Office for Safety in the Health Care of the Federal Republic of Germany at a later date.

Immediate message

§ 10. 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.

References to acts of the European Union

§ 11. This Regulation implements the following directives of the European Union:

1.

Directive 2001 /82/EEC;

2.

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. OJ L 136, 30.6.30. 04 2004 p. 58.

entry into force

§ 12. With the entry into force of this Regulation, the Regulation on Pharmacovigilance Requirements and Pharmacovigilance Applications 2006 (Pharmacovigilance Regulation 2006-PhVO 2006), BGBl. II No 472/2005, as amended by the BGBl Regulation. II No 40/2009, except for force.

Stöger