Amendment To The Medicines Act

Original Language Title: Änderung des Arzneimittelgesetzes

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$20 per month, or Get a Day Pass for only USD$4.99.

110. Federal law amending the Medicines Act

The National Council has decided:

The Drug Law, BGBl. No. 185/1983, as last amended by the Federal Law BGBl. I n ° 146/2009, shall be amended as follows:

1. In accordance with Article 1 (11), the following paragraph 11a is inserted:

"(11a)" Biological medicinal products " means medicinal products whose active substance is a biological substance. A biological substance is a substance which is of biological origin or is produced from biological origin material and for its characterisation and quality determination physical, chemical and biological tests and the assessment of the the production process and its control are necessary. Biological medicinal products shall include immunological proprietary medicinal products, proprietary medicinal products manufactured using human blood or plasma as a starting material, proprietary medicinal products according to Z 1 and 1a of the Annex to the Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, OJ L 327, 30.11.2004, p. No. OJ L 136 of 30.04.2004 p. 1, as last amended by Regulation (EU) No 1235/2010, OJ L 136, 31.5.2010, p. No. OJ L 348, 31.12.2010, p. 1.

2. Section 2a (3) Z 1 reads as follows:

" 1.

the proprietary medicinal product is used exclusively under the conditions set out in the authorisation or registration, "

3. § 2b (1) reads:

"(1)" side effect " of a medicinal product for human use is a harmful and unintended reaction to the medicinal product. "Adverse effect" of a veterinary medicinal product is a harmful and unintended reaction to the medicinal product when used in the intended use. "

4. § 2b (7) and (8), the following paragraphs 9 to 16 are added:

"(7)" Risk management system " means a series of pharmacovigilance activities and measures to identify, describe, avoid or minimise risks related to proprietary medicinal products, including the assessment of the effectiveness of such activities and activities.

(8) "Risk Management Plan" shall be a detailed description of the risk management system.

(9) "pharmacovigilance system" means a system which the marketing authorisation holder or To comply with the tasks and duties referred to in Section IX, and to ensure that the safety and security of the health and safety of the health and safety is carried out by the holder of a registration and the Federal Office for Health Security. registered proprietary medicinal products and the discovery of all changes in the benefit/risk ratio.

(10) "Pharmacovigilance (pharmacovigilance master file)" is a detailed description of the system of pharmacovigilance, which the marketing authorisation holder applies to one or more authorised medicinal products.

(11) "pharmacovigilance officer" means a suitably qualified person responsible for the supervision of medicinal products.

(12) 'Regular updated report on the safety of medicinal products (PSUR)' shall be a report with the records referred to in Article 75 of Directive 2001 /82/EC or Article 107b of Directive 2001 /83/EC.

(13) 'post-authorisation safety study' means any clinical trial or non-interventional study of an approved or non-interventional study. In order to identify, describe or quantify a safety risk, the registered proprietary medicinal product is to confirm the safety profile of a medicinal product or to measure the efficiency of risk management measures.

(14) "Pharmacovigilance Risk Assessment Committee (PRAC)" shall be the Committee established by the Agency in accordance with Article 56 of Regulation (EC) No 726/2004.

(15) 'Eudravigilance database' shall be the database operated by the Agency in accordance with Article 24 of Regulation (EC) No 726/2004.

(16) 'Data archive for the regularly updated safety reports' shall be the data archive operated by the Agency in accordance with Article 25a of Regulation (EC) No 726/2004. '

5. § 7 para. 1 Z 2 reads:

" 2.

Proprietary medicinal products, their removal or import in accordance with the Proprietary Medicinal Products Import Act 2010, BGBl. I No 79/2010, or '

6. According to Article 7 (6e), the following paragraph 6f is inserted:

"(6f) Non-proprietary medicinal products subject to authorisation in accordance with paragraph 1 of this Article shall apply to newly-remaining medicinal products."

7. In § § 8 (2), (81a) and (86), the citation shall be "Medicinal goods import law 2002" by quoting "Medicinal goods import law 2010" replaced.

8. In Sections 9a (1) Z 8, 18a (2) and § 54 (1), the abbreviation shall be: "SPC" by the abbreviation "SmPC" replaced.

9. § 9a (1) Z 22 reads as follows:

" 22.

the risk management plan for the relevant proprietary medicinal product, together with a summary in accordance with paragraph 4, "

10. § 9a (1) Z 34 reads:

" 34.

for veterinary medicinal products, proof that the applicant has a pharmacovigilance responsible and the necessary infrastructure, in order to ensure that any adverse event occurring within the European Economic Area or in a Third country is suspected of reporting. For medicinal products for human use, a summary of the pharmacovigilance system of the applicant, which shall in any case have to be included:

a)

the evidence that the applicant has a pharmacovigilance officer,

b)

the place of living and activities of pharmacovigilance in the European Economic Area,

c)

the declaration, signed by the applicant, that it has the necessary means to comply with its obligations under Section IX; and

d)

the indication of the place where the pharmacovigilance stock documentation is carried out. "

(11) In § 9a, paragraphs 5 and 6 are given the name "(6)" and "(7)" , (4) and (5) are:

" (4) The risk management system shall be proportionate to the identified and potential risks of the proprietary medicinal product and to the need for data on safety after authorisation or Registration. In the case of veterinary medicinal products, a risk-management plan shall be submitted only if this is necessary in view of the identified and potential risks of the proprietary medicinal product, by way of derogation from paragraph 1 (22).

(5) In addition to the information referred to in paragraphs 1 to 4, an application for authorisation shall be accompanied, where appropriate, by:

1.

copies of any marketing authorisations issued in another Contracting Party to the Agreement on the European Economic Area or to a third country for the medicinal product concerned, together with a list of the Contracting Parties of the Agreement on the European Economic Area, in which a request for authorisation, as laid down in Directive 2001 /83/EC or Directive 2001 /82/EC, is examined;

2.

in the case of medicinal products for human use, a summary of the safety data, including the available data from the regular updated reports on the safety of medicinal products and the reports of suspected adverse reactions other Contracting Parties to the Agreement on the European Economic Area or a third country;

3.

the copies of the summary of product characteristics (SmPC) proposed by the applicant or approved by the competent national authorities, and the information on the use of the product;

4.

the details of any decision to disregard the authorisation in another Contracting Party of the European Economic Area or in a third country, and the reasons for that decision; and

5.

a copy of the designation of the proprietary medicinal product as a rare disease medicinal product in accordance with Regulation (EC) No 141/2000 on orphan medicinal products, OJ L 327, 30.12.2000, p. No. 1., as amended by Regulation (EC) No 596/2009, OJ L 327, 22.12.2009, p. No. OJ L 188 of 18.07.2009 S 14. "

12. In § § 10 (4) (Z) 2, 10 (5) and (7), 10a (4) (1), (3), (3), (2), (4), (4), (4), (5) and (97) of the introduction, the word shall be given "Community" by the word "Union" replaced.

13. The title before § 15 reads:

"Fachinformation (Summary of Product Properties-SmPC)"

14. § 15 para. 2 Z 4 lit. h is:

" h)

Adverse reactions which may occur when used in intended use, "

15. The Word "and" at the end of Section 15 (2) of the Z 11, the following shall be replaced by a paint, the item at the end of section 15 (2) (12) shall be replaced by a paint, the following points (13) and (14) shall be added:

" 13.

in the case of proprietary medicinal products on the list referred to in Article 23 of Regulation (EC) No 726/2004, the following statement: 'This medicinal product shall be subject to additional supervision.' This declaration must precede the black symbol in accordance with Article 23 of this Regulation and shall be followed by an appropriate standardised explanatory statement in accordance with Article 23 (5) of this Regulation, and

14.

in the case of medicinal products for human use, an indication by which doctors, dentists, dentists, midwives and pharmacists, in so far as they are not subject to the obligation to notify as the authorisation holder, are expressly requested, suspected adverse reactions to the Federal Office for To report security in the health sector. "

16. § 15 para. 3 Final sentence reads:

" The information referred to in paragraph 2 Z 5 lit. c and Z 14 are omitted. "

17. In § 15 para. 6, the quote is "Regulations (EC) No 1084/2003 or Regulation (EC) No 1085/2003" by quoting "Regulation (EC) No 1234/2008" replaced.

18. § 16 para. 2 Z 9 reads:

" 9.

a description of the adverse reactions which may occur in the course of intended use and the countermeasures to be taken, where appropriate, "

19. The point at the end of section 16 (2) Z 18 shall be replaced by a paint, the following Z 19 and 20 shall be added:

" 19.

in the case of proprietary medicinal products on the list referred to in Article 23 of Regulation (EC) No 726/2004, the following statement: 'This medicinal product shall be subject to additional supervision.' This declaration must precede the black symbol in accordance with Article 23 of this Regulation and shall be followed by an appropriate standardised explanatory statement in accordance with Article 23 (5) of this Regulation; and

20.

in the case of medicinal products for human use, an indication that patients are expressly requested to inform their doctors, dentists or pharmacists, or to report directly to the Federal Office for Safety in Health Care, suspected adverse reactions, where the different types of reporting channels available are to be indicated. "

20. § 18 (3) reads:

" (3) The authorisation or registration of a proprietary medicinal product shall be granted under conditions or conditions where it is intended for the protection of human or animal health, for the safety of medicinal products or for the control of the disease. are required. These may include in particular:

1.

certain measures contained in the risk management system designed to ensure the safe use of the proprietary medicinal product;

2.

the conduct of post-authorisation safety studies;

3.

obligations with regard to the collection or reporting of suspected adverse reactions, which go beyond the obligations laid down in Section IX,

4.

any other conditions or restrictions with regard to the safe and effective use of the proprietary medicinal product;

5.

Operate a risk-free pharmacovigilance system and

6.

Conduct of efficacy studies after authorisation where there are concerns about individual aspects of the efficacy of the proprietary medicinal product, which may not be assessed until after they have been placed on the market. "

21. § 18b (1) reads:

"(1) Competent national authority within the meaning of Regulation (EC) No 726/2004 is the Federal Office for Safety in Health."

22. In accordance with section 19 (3), the following paragraph 4 is added:

" (4) By way of derogation from paragraph 1, an application for authorisation shall not be dismissed if the applicant can demonstrate that he does not have complete data on security from objectively comprehensible reasons set out in Annex I to Directive 2001 /83/EC or effectiveness in the case of intended use. The authorisation shall be granted under conditions or conditions which, in particular, shall be subject to the safety of the proprietary medicinal product, the obligation to inform the Federal Office for Safety in the Health Care of all incidents relating to its the application and the measures to be taken. The authorisation must also be granted under the condition that, as long as an annual evaluation of the existence of the admission requirements has to be carried out, there is no complete data on safety and efficacy. The marketing authorisation holder shall submit all available updated data to the Federal Office for Health and Safety in the health sector on an annual basis. "

23. According to § 19, the following § § 19a and 19b are inserted:

" § 19a. (1) Conditions or conditions pursuant to section 18 (3) may also be required after consultation of the marketing authorisation holder or the holder of the registration.

(2) The conduct of a post-authorisation safety study shall be prescribable if there are concerns about the risks of the proprietary medicinal product. The implementation of an efficacy study after approval is to be prescribable if findings on the disease or the clinical methodology suggest that earlier assessments of the efficacy may need to be significantly corrected. In any case, the objectives of the study, a time frame for their implementation and the presentation of the results, are also to be presented.

(3) The advance of the obligations referred to in paragraph 2 shall be deemed to be a modification of the authorisation and the obligation attached to the authorisation. The marketing authorisation holder shall update his/her risk management system accordingly.

(4) Subject to the concerns referred to in paragraph 2 concerning the risks of more than one proprietary medicinal product, the Federal Office for Health Safety has to refer the Pharmacovigilance Committee (PRAC) to the Committee for Risk Assessment. In accordance with the recommendation of this committee, the Federal Office shall encourage all marketing authorisation holders concerned to carry out a joint safety study after authorisation.

(5) The Federal Minister of Health may, by means of a regulation, adopt detailed rules for the implementation of efficacy studies after authorisation, in particular as regards the conditions under which they may be prescribed.

§ 19b. The Federal Office for Health Security is obliged to inform the Agency of all authorisations granted under conditions or conditions pursuant to Sections 18 (3), 19 (4) and 19a (1) and (2) (2) and (2). "

Section 20 (2) reads as follows:

" (2) The marketing authorisation holder of a medicinal product for human use or the registrant of a traditional herbal, homeopathic or pharmacist's own proprietary medicinal product can at the Federal Office for Safety in the Public Health at the earliest four years after the legal force of the admissions and/or Registration certificate no later than nine months before the end of five years after the legal force of the admissions or registration period. the application for an extension of the authorisation, or Register if the approval or Registration requirements according to the state of the sciences are given. To this end, the admissions and/or Registration holder a consolidated version of the admissions or to submit registration documents in respect of quality, safety and efficacy, in which all the documents have been submitted since the granting of the authorisation or Registration changes have been taken into account. It shall also take into account the assessments of data from the reports of suspected adverse reactions and the regular updated reports on the safety of medicinal products. Where a consolidated version of these documents is submitted in due time and in full, the authorisation shall remain: Registration until the decision of the Federal Office for Health Security on the renewal of the authorisation. Registration valid. "

Section 20 (4) reads as follows:

" (4) If the authorisation or The Federal Office for Safety in Health extends the registration pursuant to para. 2 and 3 without any time limit, unless the Federal Office for Safety in Health is responsible for pharmacovigilance reasons, including one for pharmacovigilance purposes. small number of persons in whom the relevant proprietary medicinal product is used, sets a further limit of five years. "

26. The following sentence shall be added to section 24 (1):

" This information includes both positive and negative results of clinical trials, which may relate not only to those mentioned in the authorisation, but to all the fields of application and population groups, and to: Non-interventional studies, as well as information on the use of the proprietary medicinal product, which goes beyond the terms of the authorisation. Conclusions drawn from assessments and recommendations published in accordance with Article 26 of Regulation (EC) No 726/2004 on the European Internet portal for medicinal products shall also be taken into account. "

27. In § 26 para. 4, the quote is "§ 5 (1) Z 6 to 11 and Z 13 to 15 Proprietary Medicinal Products Import Act 2002" by quoting "§ 11 (1) Z 6 to 10 and 12 to 14 of the Act on Proprietary Medicinal Products 2010" replaced.

28. In § 26 (8), after the word order "Proprietary medicinal products referred to in paragraphs 1 and 2" the phrase "or other biological proprietary medicinal products" inserted.

29. The title before § 27 reads:

"Internet portal for medicinal products and speciality registries"

30. § 27 (3) deleted, Section 27 (4) is given the name "(3)" .

31. § 27 (5) shall be replaced by the following paragraphs 4 to 6:

" (4) The Federal Office for Health Security has an Internet portal for medicines to operate. This shall be used to inform the public and to the transport of medicinal products in respect of medicinal products, and shall be linked to the European Internet portal established pursuant to Article 26 of Regulation (EC) No 726/2004.

(5) In this portal, each authorisation, any registration within the meaning of paragraph 1 (2) to (4), any authorisation pursuant to § 10c and any modification of a proprietary medicinal product which may be relevant for its identification by the user or pharmacist, shall be: without delay, and no later than two months after their release, to be published in general. Furthermore, the Federal Office for Health Security has the approved technical information and the approved use information as well as its approved changes and any conditions or conditions for admission in accordance with § § 18 (3) and (19) (4) and 19a (1) and (2), which are based on pharmacovigilance reasons, and to publish the time-limits for their fulfilment in general terms. Prior to publication, the marketing authorisation and/or To hear the registration holder.

(6) The Federal Office for Safety in Health is obliged to provide any opinion (assessment report as well as the opinion on the opinions issued in the admission or marketing authorisation respectively) in connection with each application for registration and registration for registration requested. Registration documents of the pharmaceutical, non-clinical pharmacological and toxicological tests and the results of the clinical trials and/or clinical trials. Trials, assessment of the risk management system and the summary of the pharmacovigilance system and, where applicable, the safety and residue tests) for each application area requested, after all for commercial reasons in the The information provided by the party has been removed without delay, but no later than three months after the date of release of the text in the full text on the Internet portal for medicinal products generally accessible. The assessment report shall publish a general summary, which shall in particular contain a section on the conditions of the application. Prior to publication, the marketing authorisation and/or To hear the registration holder. "

32. § 41 (2) Z 7 reads:

" 7.

a representative of a representative disability organization, as well as a representative of the senior citizens, who is a senior citizen organization in accordance with the Federal Senior Citizens ' Act, BGBl. I No 84/1998,

33. § 48 (3) reads:

" (3) The Federal Minister for Health shall have, if this is due to pharmaceutical safety reasons, to comply with international scientific standards or Community legal obligations or to verify compliance with the provisions of the fifth section is required, by means of a regulation on the implementation of non-interventional studies, a reporting obligation for non-interventional studies, the reporting obligation, the scope of the reporting obligation and the Management of a register for non-interventional studies , including any publicly accessible part of that register. "

34. According to Article 49a (1), the following paragraph 1a is inserted:

"(1a) In order to clarify issues of demarcation of medicinal products for medical devices, the Advisory Board shall meet in accordance with section 1 in joint session with the Advisory Board pursuant to § 5b Medical Devices Act (classification and classification advisory board) in accordance with Section 5b."

§ 50a (1) Z 2 reads:

" 2.

registered traditional herbal and registered pharmacies ' own proprietary medicinal products, "

36. § 50a (3) Z 3 reads:

" 3.

are not compatible with labelling, use or technical information (summary of product characteristics-SmPC). "

37. In accordance with § 50a (3), the following paragraph 4 is added:

" (4) lay advertising shall not contain statements which go beyond the labelling, use or technical information (summary of product characteristics-SmPC). Professional advertising may contain statements which supplement the statements in terms of labelling, use or subject information (summary of product properties-SmPC) if they are not in contradiction with these statements, but rather these statements confirm or specify in a sense to be agreed with them without falsifying them. "

38. § 52 (3) reads:

' (3) In addition to paragraph 2, amateur advertising for traditional herbal medicinal products shall contain a written reference to the fact that it is a traditional herbal medicinal product for use in a given field of application; or certain fields of application are exclusively based on long-standing use. "

39. In § 60 (4), the phrase "an official" through the phrase "a staff member" replaced.

40. § 62 para. 2 Z 7 reads:

" 7.

Establishments entitled to supply medicinal products in accordance with Article 59 (3), (4), (7a) and (8), "

41. In § 67 (1), the second sentence is deleted.

42. The following sentence is added to Section 67 (4):

"The Federal Office for Health Security has to cooperate with the Agency in the coordination of inspections in third countries and informs them about planned and carried out inspections."

43. § 68 (6) deleted.

44. The title of the IX. Section is:

"Market surveillance and pharmacovigilance"

45. § § 75 to 75c together with the headings are:

" General principles

§ 75. (1) The interpretation of the principles of pharmacovigilance shall be governed by the generally accepted scientific principles and requirements set out in the guidelines on good practice in the field of good practice established by the European Commission. Pharmacovigilance.

(2) In so far as authorisation holders are addressed in this section, these provisions shall also apply to holders of a traditional herbal medicinal product specialisation.

(3) The Federal Office for Health and Safety has a system to operate a system designed to prevent medicinal products that are suspected to be hazardous to health.

Authorisation

Section 75a. The Federal Minister of Health has adopted a regulation laying down detailed rules on the need for detailed information and the functioning of the pharmacovigilance system, in so far as this is necessary in view of the need for thorough and rapid information and the functioning of the system of pharmacovigilance.

1.

the categories of side effects to be reported with regard to their frequency, severity and scientific relevance; and

2.

Content, scope and form of the message.

Pharmacovigilance system of the Federal Office for Safety in Health Care

§ 75b. (1) The Federal Office for Safety in Health has a pharmacovigilance system to guide the collection of information relevant to the monitoring of medicinal products and their scientific evaluation and participation in the health care system. Pharmacovigilance activities of the European Union shall be used.

(2) The pharmacovigilance system shall provide information on the risks of medicinal products to patients ' health or public health. This information shall, in particular, affect adverse reactions to medicinal products for human use, including adverse reactions associated with occupational exposure to medicinal products. Side effects of veterinary medicinal products and adverse reactions to people related to the use of veterinary medicinal products are also to be collected.

(3) The Federal Office for Health and Safety (Bundesamt für Sicherheit im Healthcare) must, within the framework of the pharmacovigilance system, evaluate all information scientifically, examine ways of minimising risks and avoid risks and, where appropriate, take measures with a view to: the authorisations or Make registrations.

(4) The system of pharmacovigilance must include a quality system that is appropriate for its purpose.

(5) The Federal Office for Health Security shall have regular audits of its pharmacovigilance system for medicinal products for human use and shall report to the Commission by 21 September 2013 at the latest and every two years thereafter.

(6) The Federal Office for Health Security has the Agency and the Commission informed at least 24 hours before a public communication on pharmacovigilance concerns relating to the use of a proprietary medicinal product, because public communications are required to protect public health.

§ 75c. (1) The Federal Office for Health and Safety (Bundesamt für Sicherheit im healthcare) has to ensure, within the framework of the pharmacovigilance system, that the following information is published on the Internet portal for medicinal products (§ 27):

1.

important information on pharmacovigilance concerns relating to the use of a medicinal product, which shall be made available to the public in a timely manner, including all personal information or confidential information; of a commercial nature, unless their disclosure is necessary for the protection of public health; prior to publication, the authorisation and/or the authorisation of the authorisation or the to hear the registrant;

2.

Summaries of the risk management plan for each proprietary medicinal product;

3.

the list of medicinal products referred to in Article 23 of Regulation (EC) No 726/2004, and

4.

Information on the different ways of reporting suspected adverse reactions by healthcare professionals and patients, including internet forms provided for this purpose.

(2) The person affected by a publication pursuant to paragraph 1 (1) (1) may request a review of the legality of the publication in a procedure to be carried out in a modest way with the Federal Office for Health in the Health Care. The Federal Office shall make the initiation of such a procedure known in the same way. If the unlawfulness of the publication is determined in the course of a review, the Federal Office shall correct the publication correctly or, at the request of the person concerned, either withdraw it or remove it from the Internet portal. "

46. The previous § § 75d to 75f are given the name "75n" to "75p" , the following § § 75d to 75m shall be inserted:

" § 75d. (1) The Federal Office for Health and Safety (Bundesamt für Sicherheit im Healthcare) has all suspected adverse reactions that have occurred in Austria and which are brought to the attention of patients with health care or patients. If necessary, the information must be completed as part of the follow-up to these reports.

(2) The Federal Office for Health Security shall send the notifications of serious suspected adverse reactions referred to in paragraph 1 electronically to the Eudravigilance database within 15 days of its receipt. It shall electronically transmit to the Eudravigilance database the notifications of non-serious suspected adverse reactions referred to in paragraph 1 within 90 days of their receipt. If necessary, the Federal Office shall also inform the marketing authorisation holder.

(3) The Federal Office for Health Security shall ensure that all appropriate measures are taken by the application of information collection methods and, if necessary, by follow-up of reports on suspected adverse reactions. in order to clearly identify biological medicinal products prescribed, sold, sold or used in Austria and reporting on their suspected adverse reactions, in accordance with a regulation in accordance with section 26 (8) of this Regulation, where the name of the proprietary medicinal product and the batch number are to be determined.

(4) The Federal Office for Safety in the Health Care has to submit reports of suspected adverse reactions as a result of an error in the use of a medicinal product to the Eudravigilance database, and this information should be provided to all To make patient safety available to competent authorities and institutions in Austria.

(5) The Federal Office for Health and Safety (Bundesamt für Sicherheit im Healthcare) has to cooperate with the Agency and the marketing authorisation holders with a view to the discovery of duplicate versions of reports on suspected adverse reactions.

§ 75e. (1) In cooperation with the Agency, the Federal Office for Health Security has the following measures to be taken:

1.

it monitors the results of risk minimisation measures, which are part of risk management plans, and the conditions and obligations in accordance with § § 18 (3), 19 (4) and 19b (1) and (2),

2.

it assesses updates to the risk management system,

3.

it evaluates the data in the Eudravigilance database to determine whether there are new or changed risks and whether the risk/benefit ratio of medicinal products is influenced by this.

(2) The Federal Office for Health Security shall inform the authorisation holder concerned and the Agency if it is recognized that new or modified risks exist or that the benefit/risk ratio of proprietary medicinal products is changed.

Pharmacovigilance inspections

§ 75f. (1) The Federal Office for Health and Safety (Bundesamt für Sicherheit im Healthcare) has periodically reviewed establishments pursuant to § 62 (1) and of these with pharmacovigilance tasks in respect of compliance with the obligations of this section.

(2) § 68 (1) to (3) shall apply mutatily.

(3) In accordance with § § 14f AVG, the contents of each pharmacovigilance inspection shall be recorded in accordance with § § 14f AVG, the contents of which shall be brought to the attention of the marketing authorisation holder by the Federal Office for Safety in Health.

(4) If the pharmacovigilance inspectorate leads to the conclusion that the marketing authorisation holder does not meet the requirements of this section, the Federal Office for Health and Safety in the health sector shall have the authorisation holder after obtaining an opinion on the to order them to be remedied. If the defect is not complied with, the Federal Office shall take measures in accordance with § 23.

(5) In the case of paragraph 4 of this Article, the Federal Office for Health Security shall inform the Agency, the Commission and the other Member States of the Union, provided that they are human medicinal products.

(6) The Federal Office for Safety in Health has to carry out the inspections in accordance with the Commission guidelines referred to in Article 111a of Directive 2001 /83/EC and in doing so with the Agency by exchanging information on planned and to cooperate.

Obligations of health professionals

§ 75g. (1) Doctors, dentists, veterinarians, dentists, midwives and, in so far as they are not subject to the obligation to notify pursuant to Article 75j, pharmacists and tradesmen who, in accordance with the 1994 Industrial Regulations, are responsible for the manufacture of medicinal products or for wholesale trade in medicinal products are entitled, and have drogists

1.

suspected adverse reactions or

2.

suspected adverse reactions in humans or

3.

the failure to make the expected efficacy or

4.

insufficient waiting time

to report to the Federal Office for Health Security without delay in accordance with a regulation in accordance with § 75a of medicinal products which have occurred in Germany and have become known to them on the basis of their professional activities.

(2) The notifiers according to paragraph 1 have to inform the Federal Office for Health Safety of all observations and data which may be of importance for the safety of medicinal products.

§ 75h. Persons who are not subject to the obligation to notify according to § § 75g and 75j, in particular patients, have the possibility of suspected adverse reactions of medicinal products to the Federal Office for Safety in Health via the Internet portal for medicinal products or to report by post.

Obligations of the marketing authorisation holder

Pharmacovigilance system

§ 75i. (1) The marketing authorisation holder of a proprietary medicinal product has to operate a pharmacovigilance system for its proprietary medicinal products.

(2) In the context of the pharmacovigilance system, the authorisation holder must:

1.

have continuously and continuously have a suitably qualified person responsible for pharmacovigilance (pharmacovigilance officer),

2.

carry out a regular pharmacovigilance documentation and at the request of the Federal Office for Health and Safety in the healthcare sector at any time within seven days,

3.

a risk management system

a)

for each individual medicinal product for human use, and

b)

for a veterinary speciality, provided that this is necessary in view of the identified and potential risks of the proprietary medicinal product,

4.

monitor the results of risk minimisation measures which are part of the risk management plan or which have been prescribed as conditions or conditions of admission in accordance with sections 18 (3), 19 (4) and 19b (1) and (2) of this Directive,

5.

Make updates to the risk management system and

6.

Pharmacovigilance data shall be monitored to determine whether there are new risks, have altered existing risks or have changed the risk-benefit ratio of proprietary medicinal products.

(3) The MAH must scientifically evaluate all information within the framework of the pharmacovigilance system, examine ways of minimising risks and avoid risks and, if necessary, take appropriate measures.

(4) The marketing authorisation holder shall be obliged to subject his pharmacovigilance system to regular audits. The most important results of the audits are to be noted in its pharmacovigilance core documentation. In accordance with the results of the audit, it has drawn up an action plan for the elimination of defects and has to comply with them. If the corrective measures are fully implemented, the note from the pharmacovigilance stock documentation may be deleted.

(5) The pharmacovigilance responsible shall be established and active in the European Economic Area and shall have the pharmacovigilance system established and managed. The marketing authorisation holder shall immediately report the name and contact details of the pharmacovigilance officer and any changes to these data to the Federal Office for Health and Safety in the health care sector and the Agency.

(6) Without prejudice to paragraph 5, the Federal Office for Health Safety may require the appointment of a contact person for pharmacovigilance issues in Austria to report to the Pharmacovigilance responsible report.

(7) The marketing authorisation holder shall be informed by the user and pharmacist of any significant changes in the information on the safety of the proprietary medicinal product in the form of labelling, subject or package leaflet, as a result of adverse reactions reports. shall forthwith inform the Commission of this.

(8) In connection with its authorised proprietary medicinal product, the marketing authorisation holder may not provide pharmacovigilance information without prior or simultaneous notification to the Federal Office for Health, Safety and Health, the Agency and the Agency for Safety and Health, to make the Commission public. The authorisation holder shall ensure that such public announcements are objective and not misleading.

Detection and reporting of suspected adverse reactions

§ 75j. (1) The marketing authorisation holder has suspected adverse reactions which have occurred in the European Economic Area and in third countries. In addition, any suspected transmission of pathogens by a proprietary medicinal product which has occurred in a third country must be recorded.

(2) The authorisation holder shall ensure that the information referred to in paragraph 1 is available in one place in the European Economic Area. It may not refuse to accept and examine reports of health professionals and patients.

(3) The marketing authorisation holder shall have information on all suspected serious adverse reactions which have occurred in the European Economic Area and in third countries within 15 days of the date on which it has become aware of the existence of such information. the Eudravigilance database. Information on all suspected non-serious adverse reactions which have occurred in the European Economic Area, the marketing authorisation holder shall be sent electronically within 90 days of the date on which it has been informed of the Eudravigilance database.

In the case of proprietary medicinal products containing active substances to which the list of publications which the Agency is monitoring pursuant to Article 27 of Regulation (EC) No 726/2004, the marketing authorisation holders shall not be obliged to take into account the suspected adverse reactions which have been reported in the following: listed in the list of medical literature cited in the list, to be transmitted to the Eudravigilance database.

(5) The authorisation holder is obliged to introduce procedures which can be used to obtain accurate and verifiable data for the scientific evaluation of reports on suspected adverse reactions. It shall collect information as part of the follow-up to these reports and transmit the updated information to the Eudravigilance database.

(6) The authorisation holder is obliged to cooperate with the Agency and the Federal Office for Safety in Health with a view to the discovery of duplicate versions of reports on suspected adverse reactions.

(7) The marketing authorisation holder shall be informed on a regular basis of the notifications in accordance with § 75g by means of the Eudravigilance database.

(8) The Federal Office for Health and Safety (Bundesamt für Sicherheit im healthcare) has to impose additional obligations on the notification of suspected adverse reactions to the marketing authorisation holder only if this is necessary for reasons of pharmacovigilance.

Regularly updated report on safety of medicinal products (PSURs)

§ 75k. (1) The holder of the authorisation shall be obliged to transmit electronically the regularly updated reports on the safety of medicinal products to the data archive for the regularly updated safety reports. These must include the following:

1.

Summaries of data of interest for the assessment of the benefits and risks of a proprietary medicinal product, including the results of any studies that may have an effect on the authorisation,

2.

a scientific assessment of the benefit/risk ratio of the drug speciality and

3.

all data relating to the volume of sales of the proprietary medicinal product as well as all the data available to it in connection with the volume of presenter, including an estimate of the number of persons applying the proprietary medicinal product.

The assessment according to Z 2 must be based on all available data, including data from clinical trials for areas of application and population groups that do not comply with the authorisation.

(2) By way of derogation from paragraph 1, the authorisation-holder, with an authorisation as a generic medicinal product or as a traditional herbal medicinal product, as well as the holder of a registration as a traditional herbal medicinal product, shall have to report regularly updated safety reports only submit the data archive for the regularly updated safety reports if:

1.

such an obligation as a condition or condition for the granting of the authorisation, or registration has been made; or

2.

A submission from the Federal Office for Health and Safety in the health sector due to concerns related to pharmacovigilance data or concerns due to the lack of regular updated reports on the safety of medicinal products for a Active substance after authorisation or Registration is arranged.

(3) The Federal Office for Health and Safety (Bundesamt für Sicherheit im Healthcare) has to prescribe in the letter of approval the rhythm of the periodic safety reports being updated. The date for the submission shall be calculated according to the prescribed rhythm as of the legal force of the approval certificate.

(4) The marketing authorisation holder, whose proprietary medicinal product is in the version of the Federal Law BGBl before the entry into force of this Federal Law. I n ° 110/2012, and for which the pre-storage rhythm and date for the periodic safety update reports has not been established in a modest way, the regular updated reports on the to submit the safety of medicinal products to the Federal Office for Safety in Health in accordance with the following guidelines:

1.

if the proprietary medicinal product has not yet been placed on the market: at least every six months after authorisation;

2.

if the proprietary medicinal product has been placed on the market: at least every six months during the first two years following the first placing on the market, once a year in the following two years and thereafter at a distance of three years, and

3.

immediately upon request by the Federal Office for Safety in the Health Care Service.

The requirements of Z 1 and 2 shall apply until a different rhythm or other reference dates have been established in a change of approval or in accordance with paragraph 6 or 7.

(5) Paragraph 4 shall also apply to the proprietary medicinal products which are authorised only in Austria and do not fall within the scope of paragraph 6.

(6) For proprietary medicinal products containing the same active substance or the same combination of active substances but subject to different authorisations, and in which the rhythm and dates for the submission of the periodic updated reports shall be submitted on: the safety of medicinal products has been harmonised, which has been made public by the Agency via the European Internet portal for medicinal products, the marketing authorisation holders concerned have the Federal Office for Safety in the Health Amendment of the authorisation to be notified. Amendments to the authorisation shall be entered into force six months after publication.

(7) authorisation holders may, for the following reasons, apply to the Committee for Medicinal Products for Human Use under Article 5 of Regulation (EC) No 726/2004 or to the coordination group under Article 27 of Directive 2001 /83/EC, for a date to be set out in the Union. , or the rhythm of the submission of regular updated reports on the safety of medicinal products shall be amended:

1.

for reasons of public health,

2.

to avoid duplication of assessments or

3.

with regard to international harmonisation.

Such requests shall be made in writing and shall be justified. Any change in the dates or the rhythm of the submission of regular updated reports on the safety of medicinal products shall be made public by the Agency via the European Internet portal for medicinal products. Affected marketing authorisation holders have to notify the Federal Office for Safety in the Health Care of the amendment of the authorisation. Amendments to the authorisation shall be entered into force six months after publication.

§ 75l. After examining and evaluating the periodic safety update report on the safety of medicinal products with a view to a change in the benefit/risk ratio, the Federal Office for Health and Safety (Bundesamt für Sicherheit im Sicherheit im Healthcare) has to do so according to the extent of if necessary, to impose conditions where necessary, or to remove the authorisation, or to place it in a dormant manner. This shall also apply in the case of a uniform assessment pursuant to Article 107e of Directive 2001 /83/EC.

§ 75m. Authorisation holders are obliged to inform the Federal Office for Safety in the Health Care and the Agency if new or altered risks exist or if it is recognized that the benefit-risk ratio of proprietary medicinal products is changed. "

47. § 75n para. 3 (new) reads:

" (3) The head of a blood depot within the meaning of Section 8f of the KAKuG, as well as the respective implementing provisions or, where there is no such execution, are the medical director of the hospital as well as established doctors, including group practices. , serious adverse events that may affect the storage or distribution of blood and blood components and may affect quality and safety, as well as serious adverse reactions occurring during or after the transfusion, and to the quality and safety of blood or blood components will be able to report immediately to the Federal Office for Safety in Health. "

48. According to § 75p, the following § 75q and heading is inserted:

" Quality Defects

§ 75q. (1) Quality defects are

1.

Defects in the sense of § 4 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.

(2) Doctors, Dentists, Veterinary Surgeons, Dentists, midwives and, in so far as they are not subject to the obligation to notify pursuant to Section 75j, pharmacists and tradesmen who, in accordance with the 1994 Commercial Code, are subject to the manufacture of medicinal products or to wholesale trade in The Federal Office for Health and Safety (Bundesamt für Sicherheit im healthcare) has to inform the Federal Office for Safety and Health of the Federal Office for Safety and Health (Bundesamt für Sicherheit im healthcare) without delay if the drug is entitled to information about quality defects that have occurred in Germany.

(3) The marketing authorisation holder shall record quality defects that have occurred in the country and have been brought to the attention of him pursuant to paragraph 2 or have otherwise come to the knowledge, and shall immediately, at the latest, the Federal Office for Safety in the Health Care but within 15 days of becoming aware of it. The marketing authorisation holder must document the original wording of the notice and keep it for five years as well as to forward it immediately to the Federal Office for Health and Safety in the health care sector upon request.

(4) If, due to the lack of quality, there is an immediate danger to life or serious and significant endangerments to health, the notification to the Federal Office for Safety in the Health Care must be made without delay.

(5) Paragraph 1 to 4 shall also apply mutatis mutally to the holder of a registration as an apothecary or homeopathic proprietary medicinal product.

(6) The provisions of paragraphs 1 to 4 shall also apply to the holder of a marketing authorisation in parallel import. In addition, the holder of a parallel import marketing authorisation has the authorisation holder or the holder of a registration as an apothecary or traditional herbal medicinal product specialising in this notification within the said period. to inform.

(7) If, due to the lack of quality, there is a significant risk to public health, the Federal Office for Health and Safety shall transmit to all the other Member States of the European Economic Area and to all possible actors in the supply chain within the country, a rapid alert message. If it is to be assumed that the proprietary medicinal product has already reached patients and there is a reasonable suspicion that a direct threat to life or serious and serious health risks is to be provided, the Federal Office for Health and Safety immediately, but at the latest within 24 hours, to inform the public about the lack of quality and the risks posed by it. Any measures already taken by the marketing authorisation holder must be taken into account. Section 75c (2) shall apply mutatily. "

49. § § 77 and 78 are inserted, the following § 78a and heading is inserted:

" § 77. If the Federal Office of Public Health is found to be in control in accordance with § 76, it is otherwise aware that a medicinal product or an active substance to this Federal Act or regulations issued pursuant to this Federal Act or the Federal Act of Germany shall be subject to the following conditions: other administrative acts, the Federal Office for Health Security has to have measures that prevent or restrict the placing on the market. Section 76b (10) may apply if necessary.

§ 78. (1) The Federal Office for Safety of Health is aware of the facts on the basis of which it is to be concerned that a medicinal product or an active substance placed on the market is a risk to life or health of humans or animals, the Federal Office for Health and Safety shall have all the measures necessary to prevent or restrict the placing on the market of the medicinal product or the active substance or the use of the medicinal product in accordance with the extent of the risk.

(2) In the event of risk of default by a medicinal product or an active substance, measures may be taken in accordance with paragraph 1

1.

even without prior procedures or

2.

shall be taken before the date on which a seizage is made.

In the case of Z 2, however, a written notice must be issued within two weeks by the Federal Office for Health Security, if the measure taken is deemed to have been repealed.

(3) The Federal Office for Health Security shall declare the medicinal product seized by it or the seized active substance as a precautionary measure to be forfeited if it has a serious and significant risk to man or to a person or to a person or to a person who is not responsible for the protection of the health of the person. The person responsible for the medicinal product or the active substance shall not ensure that the medicinal product or the active substance is not placed on the market after its release.

Provisional seizure

§ 78a. Bodies of the Federal Office for Health Security have to provisionally seize medicinal products or active substances on the basis of the protection objectives of this Federal Act, if there are reasonable grounds for suspecting that such medicinal products are

1.

are placed on the market, contrary to the provisions of this Federal Act, or to regulations or other administrative acts based thereon; and

2.

a hazard to the life or health of humans or animals.

The regulations of § 76b concerning the provisional seizure by supervisory bodies and the measures of the district administrative authorities in the administrative criminal proceedings as well as § 76c are to be applied. "

Section 83 (1) Z 13 and 14 reads as follows:

" 13.

as the marketing authorisation holder, holder of a registration or holder of a parallel import marketing authorisation, its obligations under the IX. Section or § 94h shall not be complied with, or

14.

the reporting obligation pursuant to § 75g or § 75n is infringed, "

51. In § 84a the annual number shall be "2002" by the year " 2010 " replaced.

Section 85a (3) reads as follows:

" (3) If the origin of the breach lies within the meaning of paragraph 1 in Austria, the claim may also be submitted by each of the in the Official Journal of the European Union by the Commission in accordance with Article 4 (3) of Directive 2009 /22/EC of 23 April 2009 on Injunctions for the protection of consumers ' interests, OJ C 327, 30.4.2004 No. 30, published posts and organisations of another Member State of the European Union, provided that:

1.

the interests protected by that body are affected in that Member State; and

2.

the purpose of the institution as indicated in the publication justifies this right of action. "

53. § 86 (4) Z 13 reads:

" 13.

the Model Protection Act 1990, BGBl. No 479/1990, "

Section 86 (4) Z 18 reads as follows:

" 18.

the New-Psychoactive-Substances-Law, BGBl. I No 146/2011, "

Section 94a (6) reads as follows:

" (6) substances or preparations of substances within the meaning of Article 1 (3) Z 8, provided that they are always produced in the same composition in advance and placed on the market under the same name in a form intended for sale in retail sale, in accordance with § 11b of the Federal Law BGBl. No 748/1988 may continue to be delivered domestily until 31 December 2013 or held in place for domestic supply, unless § 3, which applies mutatily to these products, is contrary to that. "

56. § 94b second sentence is deleted.

57. In accordance with § 94g, the following § 94h with headline is inserted:

" Transitional law to the Novelle BGBl. I No 110/2012

§ 94h. (1) § 9a (1) Z 22 in the version of the Federal Law BGBl. I No 110/2012 shall not apply to authorisations or Registrations of proprietary medicinal products prior to the entry into force of this Federal Law in the version of the Federal Law BGBl. I No 110/2012.

(2) Section 9a (1) Z 34 in the version of the Federal Law BGBl. I No 110/2012 shall not apply to authorisations or Registrations of medicinal products for human use, which prior to the entry into force of this Federal Law in the version of the Federal Law BGBl. I No 110/2012. In these cases, the marketing authorisation holders or Holder of a registration of the obligation to lead a pharmacovigilance stock documentation as of the legal force of the renewal of the authorisation or Registration, but no later than 21 July 2015.

(3) The technical and service information of proprietary medicinal products which prior to the entry into force of this Federal Law in the version of the Federal Law BGBl. In accordance with Article 15 (2) of Regulation (EC) No 110/2012, the provisions of Section 15 (2) (13) and (16) (2) (19) of Regulation (EC) No 726/2004 must be in accordance with the provisions of Article 15 (2) of Regulation (EC) No 726/2004 at the earliest possible date, but no later than three months after expulsion.

(4) The technical and service information of proprietary medicinal products which prior to the entry into force of this Federal Law in the version of the Federal Law BGBl. I No 110/2012 have been admitted or registered in accordance with § § 15 (2) Z 14 and 16 (2) (2) (20) at the ehest possible date, but at the latest with 1 July 2014.

(5) In the event that the change in a specialist or in-use information is only the adjustment according to para. 3 or 4, the change of the information is to be reported by the marketing authorisation holder or the holder of a registration to the Federal Office for Safety in Health.

(6) § 20 (2) in the version of the Federal Law BGBl. I No 110/2012 applies to proprietary medicinal products, their approval or Registration after 21 April 2013 would end.

(7) For veterinary specialties, § § 75a (3) and (4) and (75b) shall apply in the version prior to the Novelle BGBl. I No 110/2012.

(8) § § 75a (3) and (4) and (75b) shall apply in the version before the Novelle BGBl for registered apothecary proprietary proprietary medicinal products. I No 110/2012.

(9) § 75b (1) and (2) in the version before the Novelle BGBl. I n ° 110/2012 also applies to the holder of a marketing authorisation for parallel import. Where a notification in accordance with § 75g relates to a proprietary medicinal product which has been transferred to Austria on the basis of a marketing authorisation for the parallel importation procedure, the Federal Office for Health and Safety in the healthcare sector shall have the holder of the authorisation for the Distribution in parallel import immediately, but no later than 15 days after the notification. The information must be provided in an anonymized form.

(10) § 75j (3) in the version of the Federal Law BGBl. I No 110/2012 shall enter into force six months after the notification of the Agency on its web portal that the Eudravigilance database has the appropriate functions. In the meantime, § 75j (3) applies, with the proviso that the reports to the Federal Office for Health and Safety are to be made and all suspected non-serious side effects of immunological proprietary medicinal products are to be reported. Proprietary medicinal products manufactured using human blood or plasma as a starting material and proprietary medicinal products on the list referred to in Article 23 of Regulation (EC) No 726/2004, which have occurred in Austria , within 90 days after the authorisation holder has become aware, the Federal Office of the Federal Republic of Germany for health safety.

(11) § 75k (1) and (2) in the version of the Federal Law BGBl. I No 110/2012, with regard to the obligation to electronically submit updated reports on the safety of medicinal products, 12 months after the Agency has been notified on its web portal, that the data archive shall be available for which has regularly updated safety reports on the relevant functions, in force. Until then, the regular updated reports on the safety of medicinal products must be submitted to the Federal Office for Health and Safety in the Health Care Sector.

(12) The Federal Office for Health Security has the Commission to inform the Commission by 22 July 2013 of the details of the system pursuant to Section 75 (3). "

58. The point at the end of § 97 Z 28 shall be replaced by a paint, the following Z 29 shall be added:

" 29.

Directive 2010 /84/EU of the European Parliament and of the Council of 15 December 2010 amending Directive 2001 /83/EC on the Community code relating to medicinal products for human use with regard to pharmacovigilance, OJ L 327, 30.12.2010, p. No. OJ L 348 of 31 December 2010, S 74, as amended by the corrigendum OJ L 348, 28.12.2010, p. No. OJ No L 21, 25. Jänner 2011, S 8. "

Fischer

Faymann