Amendment To The Medicines Act

Original Language Title: Änderung des Arzneimittelgesetzes

Read the untranslated law here: https://www.global-regulation.com/law/austria/2996959/nderung-des-arzneimittelgesetzes.html

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110. Federal law that modifies the medicines Act

The National Council has decided:

The medicines Act, Federal Law Gazette No. 185/1983, amended by Federal Law Gazette I no. 146/2009, is amended as follows:

1. pursuant to section 1 para 11, 11a the following paragraph shall be inserted:

"(11a)"Biological medicines"are medicinal products whose Wirkstoff is a biological substance. A biological substance is a substance which biological origin is or is created from organic origin material and its characterization and determination of quality physical, chemical and biological testing and assessing of the production process and its control are required. Biological medicinal products include immunological medicinal products, medicinal products manufactured using human blood or blood plasma as a starting material, proprietary medicinal products in accordance with no. 1 and 1a of the annex of to Regulation (EC) No. 726/2004 laying down Community procedures for the authorisation and supervision of human and veterinary use and establishing a European Medicines Agency, OJ No. L 136 of 30.04.2004 p. 1, as last amended by Regulation (EC) no 1235/2010, OJ "No. L 348 of 31 S. 1."

2. § 2a para 3 No. 1 is: "1. the medicinal exclusively under the conditions laid down in the authorisation or registration is used" 3. § 2 b paragraph 1 is:

"(1)"side effect"of medicinal products is a harmful and unintended response to the drug." Side effect"of a veterinary medicinal product is a harmful and unintended response to the drug when used properly."

4. paragraph 2 (b) paragraph 7 and 8, following paragraph 9 to 16 are attached:

"(7)"Risk management system"is a set of pharmacovigilance activities and measures the risks; to identified, described, avoided relating to proprietary medicinal products or minimized This includes also the assessment of the effectiveness of such activities and measures.

(8) "Risk management plan" is a detailed description of the risk management system.

(9) "Pharmacovigilance system" is a system which the marketing authorisation holder or holder of the registration and the Federal Office for security in healthcare apply to comply with the tasks listed in section IX and duties and is used to monitor the safety of medicinal products authorised or registered, and the discovery of any changes of the risk-benefit balance.

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

(11) "Pharmakovigilanzverantwortlicher" is an appropriately qualified person responsible for pharmacovigilance.

(12) "Regular updated report on the safety of medicinal products (PSUR)" is a report with the in article 75 of Directive 2001/82/EC or article of 107 b of Directive 2001/83/EC records.

(13) "Safety study after approval" is any clinical examination or non - Interventional study on an approved or registered medicinal which is carried out to determine a security risk, to describe or quantify, to confirm the safety profile of a drug or to measure the effectiveness of risk management measures.

(14) "The Committee for risk assessment in pharmacovigilance (PRAC)" is the agency according to article 56 of Regulation (EC) No. 726 / 2004-oriented Committee.

(15) "Eudravigilanz database" is the database operated by the Agency in accordance with article 24 of Regulation (EC) No. 726/2004.

"(16)"Data archive for the regularly updated reports"is the records center operated by the Agency in accordance with article 25a of Regulation (EC) No. 726/2004."

5. § 7 para 1 No. 2 is: "2 medicinal products, whose removal or import after the drug importation Act 2010, Federal Law Gazette I no. 79/2010, takes place, or" 6 according to § 7 paragraph 6e 6f the following paragraph inserted:

"(6f) not considered medicinal products which are subject to approval in accordance with paragraph 1, neuverblisterte medicines."

7. in §§ 8 par. 2, 81a and 86 respectively the quote "Drug importation Act 2002" the quote "Drug importation Act 2010" replaces.

8 in the §§ 9a para 1 No. 8, 18a, paragraph 2, and article 54, paragraph 1, the abbreviation "SPC" is replaced by the acronym "SmPC".

9 § 9a para 1 No. 22 is: "22 the risk management plan for the relevant medical specialty, along with a summary in accordance with paragraph 4," 10 § 9a, para 1, no. 34 is: "34. for veterinary medicinal products is the proof that the applicant has a Pharmakovigilanzverantwortlichen and the necessary infrastructure, to each side effect, which occurred within the European economic area or in a third country suspected , to report. "Für Humanarzneispezialitäten eine Zusammenfassung des Pharmakovigilanz-Systems des Antragstellers, das jedenfalls zu umfassen hat: a) the proof that the applicant has a Pharmakovigilanzverantwortlichen, b) residential and transitory of the Pharmakovigilanzverantwortlichen in the European economic area, c) the Declaration signed by the applicant, that he has the necessary resources to meet its obligations under section and d to comply with IX) the indication of the place where the pharmacovigilance system master file will be run."

11. in section 9a, para 5 and 6 receive the designation (6) and (7), par. 4 and 5 are:

"(4) the risk management system must be in proportion to the identified and potential risks of the medicinal and needs data on the safety after authorisation or registration. For veterinary medicinal products, a risk management plan to present only if this is necessary with regard to the identified and potential risks of the medicinal is by way of derogation from paragraph 1 Z 22.

(5) in addition to the information referred to in paragraphs 1 to 4 may be a request for approval to add: 1. copies of all in another party of the agreement on the European economic area or permits granted to a third country for the placing on the market of the relevant medicinal, along with a list of the Contracting Parties of the agreement on the European economic area, in which a of Directive 2001/83/EC or Directive 2001/82/EC of application for approval; tested

2. for human medicinal products, a summary of safety data, including the data available from the regular updated reports on the safety of medicines and the reports of suspected adverse reactions from other parties of the agreement on the European economic area or in a third country;

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

4. details of all decisions to the refusal of the marketing authorization in another party of the European economic area or in a third country and the reasons for this decision and 5. the copy of the expulsion of the medicinal as medicines for rare conditions under Regulation (EC) No. 141/2000 on orphan medicinal products for orphan, OJ No. L 18 of the 22.01.2000 p. 1, as amended by Regulation (EC) No. 596/2009, OJ "No. L 188 of July 18, 2009 S 14."

12. in section 10, paragraph 4 Nos. 2, 10 para 5 and 7, 10a 4 Z 1, 26a para 3, 28 para of 2, 67 par. of 4, 80 paragraph 5 and 97 introductory phrase is each replaced the word 'Community' by the word 'Union'.

13. the heading before section 15 is as follows:

"Prescribing information (summary of product characteristics SmPC)"

14 § 15 para 2 No. 4 lit. h is: "h) side effects that can occur during normal conditions of use" 15. The word "and" at the end of article 15 par. 2, Z 11 is replaced by a comma, the point Z 12 at the end of § 15 para 2 is replaced by a comma, following Z 13 and 14 are attached: "13 for medicinal products which are on the list referred to in article 23 of Regulation (EC) No. 726/2004, following declaration:"This drug is subject to an additional monitoring."" "This Declaration has the black symbol referred to in article 23 of this regulation go ahead and follow a suitable standardized explanatory sentence under article 23 paragraph 5 of this regulation, and a note by the doctors, dentists, dentist, midwives and pharmacists, as far as they are subject to not the notification as the marketing authorisation holder, expressly asks 14 in human medicinal to report suspected adverse reactions to the Federal Office for security in the health care sector."

16 § 15 ABS. 3 final sentence reads:

"The information according to para 2 No. 5 lit. c and Z 14 be dropped."

17. in article 15, paragraph 6, the quote is "regulations (EC) No. 1084/2003 or regulation (EC) No 1085/2003" by the quote "Regulation (EC) No 1234/2008" replaced.

18 § 16 par. 2 No. 9 is: "9 a description of the adverse reactions which can occur during normal conditions of use, and, where appropriate, action to be taken case,"


19. the point is replaced at the end of section 16 paragraph 2 Z 18 by a comma, following Z 19 and 20 are attached: "19 for medicinal products which are on the list referred to in article 23 of Regulation (EC) No. 726/2004, following declaration:"This drug is subject to an additional monitoring."" This declaration must precede the black icon in accordance with article 23 of this regulation and a suitable standardized set of explanatory paragraph 5 of this regulation follow according to article 23 and 20th at human medicinal a note, expressly prompts the patient to inform suspected adverse reactions to their doctors, dentists or pharmacists or immediately to report the Federal Office for security in healthcare, where the available different types of communication channels to be."

20 paragraph 18 para 3:

"(3) the authorisation or registration of a pharmaceutical speciality is to see notices of payment due by the terms or conditions, if these are necessary for the protection of the health of humans or animals, for drug safety or an effective disease control. This may include in particular the following: 1 certain in the risk management system included measures to ensure of the safe use of medicinal, 2 implementation of post-authorisation safety studies after approval, 3. obligations in the terms of the acquisition or message suspected side effects that go beyond the obligations laid down in section IX, 4. other conditions or restrictions with regard to the safe and effective use of medicinal, 5. operate a pharmacovigilance system riskenadäquaten and 6 implementation of efficacy studies after approval ", where there are concerns about particular aspects of the efficacy of the medicinal, can only be judged according to their placing on the market."

21 paragraph 18 b paragraph 1:

"(1) competent national authority in the sense of Regulation (EC) No. 726/2004 is the Federal Office for security in the health care sector."

22 according to article 19, para. 3, the following paragraph 4 is added:

"An application for marketing authorization not to reject if the applicant can demonstrate that he can present no complete data on safety or efficacy in the intended reasons objectively comprehensible, referred to in annex I to Directive 2001/83/EC is (4) by way of derogation from paragraph 1. Admission is granted, affecting in particular the safety of medicinal, the obligation to inform of the Federal Office for security in the healthcare to all incidents relating to his application and the measures to be taken under terms or conditions. The admission is to grant that as long as an annual evaluation of the existence of the prerequisites to be made has, as no complete data on safety and effectiveness are also under the rest. The marketing authorisation holder has to submit annually all available updated data to the Federal Office for security in healthcare to do so."

23. under article 19, following sections 19a and 19B shall be inserted:

"article 19a. (1) requirements or conditions according to § 18 para 3 may be prescribed later after hearing of the admissions or registration holder.

(2) the implementation of a post-authorisation safety study is after approval to prescribe, if there are concerns about the risks of medicinal. Conducting an effectiveness study is after approval to prescribe, if evidence about the disease or the clinical methodology indicates that previous evaluations of effectiveness must be corrected may significantly. There are in any case also the objectives of the study, a time frame for their implementation and the submission of the results to be.

(3) the notices of payment due of the obligations referred to in paragraph 2 is considered associated Edition amend the authorisation and approval. The marketing authorisation holder has its risk management system to update accordingly.

(4) the concerns referred to in paragraph 2 to the risks relate more as a medicinal, the Federal Office for security in the health care sector has to deal with the Committee for risk assessment in pharmacovigilance (PRAC). According to the recommendation of this Committee, the Federal Office suggests all concerned marketing authorisation holders, carry out a joint study of safety after approval.

(5) the Federal Minister for health may adopt further rules to carry out efficacy studies after approval through regulation, in particular as regards the conditions under which they may be prescribed.

§ 19 b. The Federal Office for security in the health care sector is obliged to inform all approvals, para of 3, 19 para 4 and 19a (1) and 2 § 18 are given according to the § under terms or conditions, which the Agency."

24 paragraph 20 paragraph 2:

"(2) the marketing authorisation holder of a human medicinal or the registration holder of a traditional herbal, homeopathic or own pharmacy medicinal can apply at the earliest four years after legal effect of registration or registration permit until at the latest nine months before the expiration of five years after legal effect of registration or registration permit the extension the authorisation or registration at the Federal Office for security in healthcare, if the licensing or registration requirements are given according to the State of the science. To this end, which has to submit a consolidated version of the accreditation or registration documents as regards quality, safety and efficacy approval or registration holder, all changes made since issuing the authorisation or registration were taken into account in the. It also reviews data from the reports of suspected adverse reactions and the regularly updated reports on the safety of medicinal products must be considered. Is a consolidated version of these documents is presented in a timely and completely, so the authorisation or registration remains valid until the decision of the Federal Office for security in healthcare on the renewal of the authorisation or registration."

25 paragraph 20 paragraph 4:

"(4) if the authorisation or registration in accordance with paragraph 2 and 3 of the Federal Office for security in healthcare is extended, it will be valid without time limit, if not the Federal Office for security in the healthcare sector for reasons of pharmacovigilance, including an insufficient number to people where the concerned medicinal is applied, constitutes a further term of five years."

26 the following sentence is added to the section 24, paragraph 1:

"This information includes both positive and negative results of clinical trials, which relate not only to those referred to in the approval, but on all application areas and population groups, and non - interventional studies, as well as information on an application of the medicine specialty, which goes beyond the provisions of the registration. Conclusions from evaluations and recommendations, which are published according to article 26 of Regulation (EC) No. 726/2004 on the European Internet portal for medicines, to take into account are also."

27. in article 26, paragraph 4, the quote is "§ 5 par. 1 Z 6 to 11 and Z of 13 to 15 drug importation Act 2002" by the quote "article 11, paragraph 1 Z 6 to 10 and 12 to 14 drug importation Act 2010" replaced.

28. in article 26, paragraph 8 is inserted after the phrase "Medicinal pursuant to paragraphs 1 and 2" the phrase "or other biological medicinal products".

29. the heading before section 27 is as follows:

"Internet portal for medicinal and pharmaceutical specialty register"

30 is article 27, para. 3, article 27 paragraph 4 is labeled (3).

31 § 27 para 5 is replaced in the following para 4 to 6:

"(4) the Federal Office for security in the healthcare system has to operate an Internet portal for medicines. This is for convenience the public and involved public on medicinal and is similar according to article 26 of Regulation (EC) No. 726 / 2004-oriented European Internet portal link.

(5) in this portal, any authorization, any registration in the sense of paragraph 1 is generally accessible to publish Z 2-4, each approval in accordance with § 10 c and any change in a medical specialty that can be immediately, for their identification by the users or pharmacist of importance at the latest, but two months after its enactment. The Federal Office for security in healthcare has the approved prescribing information and the approved instructions and their approved changes and any conditions or requirements for admission according to the § 18 para 3, generally accessible to publish 19 para 4 and 19a para 1 and 2, which have been made from Pharmakovigilanzgründen, and the deadlines for their fulfilment. Before publication, the authorisation or registration holder is to listen.


(6) the Federal Office for security in the health care sector is obliged, each opinion relating to each applied for admission and registration to the registry (assessment report and the opinion on the results of the pharmaceutical, non-clinical pharmacological and toxicological tests contained in the approval or the registration documents and the results of clinical trials or trials, the assessment of the risk management system and the summary of the pharmacovigilance system and, where appropriate, the safety and residue tests) for each proposed field of application , after all information this for commercial reasons in the party's confidentiality interest are removed immediately, but no later than three months after issuing the notice in full text on the Internet portal for medicines widely available to publish. With the assessment report, a generally understandable summary is to publish, which must contain in particular a section on the conditions of the application. Prior to publication of licensing or registration holder can be heard."

32. § 41 para 2 No. 7 is: "7 a representative of a representative organization of people with disabilities, as well as a representative of senior citizens, which I 84/1998, belongs to no. a senior organization in accordance with the Federal senior law, BGBl.," 33. § 48 para 3 is:

"(3) the Federal Minister of health has provided this section is required for reasons of drug safety, compliance with international scientific standards or community obligations or to the verification of compliance with the provisions of the regulation to adopt regulations on the implementation of non - interventional studies, reporting obligations for non - interventional studies, committed to the message, the scope of the reporting obligation, as well as the maintenance of a register for non - interventional studies including any public part of this register."

34. pursuant to section 49a para 1, the following paragraph 1a is inserted:

"(1a) for the clarification of ambiguous responsibilities of pharmaceuticals to medical devices, the Advisory Board referred to in paragraph 1 in joint session must days 5b medical product law (delimitation and classification Advisory Committee) with the Advisory Board pursuant to §."

35. § 50a para 1 No. 2 is: "2. registered traditional herbal and registered pharmacy own medicinal products" 36. § 50a para 3 Z 3 is: "3. with marking, use or trade information (summary of product characteristics - SmPC) are compatible."

37. According to § 50a para 3, the following paragraph 4 is added:

"(4) lay advertising must contain no statements that go beyond the labelling, use or trade information (summary of product characteristics - SmPC). Trade advertising must contain statements which complement the statements in labeling, use or trade information (summary of product characteristics - SmPC), when these statements not in opposition stand, but these statements confirm or clarify in a sense to be agreed with them, without distorting them."

38. paragraph 52 para 3:

"(3) lay advertising for traditional herbal medicinal products has the written note to para. 2 to contain, that it's a traditional herbal medicine specialty for use for a particular application area or specific applications only on the basis of long-standing use."

39. in article 60, paragraph 4, the phrase "an official" is replaced by the phrase "a servant".

40. § 62 para 2 No. 7 is: "7 farms, in accordance with section 59 para 3, 4, 7a and 8 to the dispensing of medicines are entitled, ' 41. In article 67, paragraph 1, the second sentence does not apply.

42. the following sentence is added to the section 67, paragraph 4:

"The Federal Office for security in the health care sector has to cooperate with the Agency in the coordination of inspections in third countries and informed them of planned and carried out inspections."

43. paragraph 6 deleted § 68.

44. the heading of IX. section is as follows:

"Market surveillance and pharmacovigilance"

45. paragraphs 75 to 75 c with headings are:

"General principles

The generally accepted scientific principles and requirements § 75. (1) for the interpretation of the principles of pharmacovigilance significantly that are contained in the guidelines drawn up by the European Commission on good practice in the field of pharmacovigilance.

(2) as far as marketing authorisation holder are addressed in this section, these provisions apply also to holder of a registration of a traditional herbal medicinal.

(3) the Federal Office for security in the health care sector has a system to operate, to prevent that medicinal products which are allegedly hazardous to health, access to patients.

Authority to issue regulations

75a. The Federal Minister of health has by regulation, insofar as this is necessary under consideration on the needs of incoming and rapid information and the functioning of the pharmacovigilance system, the more detailed provisions to adopt about 1 in terms of their frequency, severity, and scientific relevance to report categories of side effects and 2 content, scope and form of the message.

Pharmacovigilance system of the Federal Office for security in healthcare

§ serves 75. (1) that has Federal Office for security in the health care sector to implement a pharmacovigilance system, the collection for the pharmacovigilance-important information and scientific evaluation and participation in the European Union's pharmacovigilance activities.

(2) in the pharmacovigilance system, information about the risks of drugs for public health or the health of the patient are to gather. This information applies in particular side effects of human medicinal products including side effects associated with occupational exposure to the medicinal. Side effects of veterinary medicines and side effects in humans related to the use of veterinary medicinal products to collect are also.

(3) the Federal Office for security in the health care sector must scientifically evaluate all information within the framework of the pharmacovigilance system, examine possibilities of Riskenminimierung and prevention and, where appropriate, take measures in terms of the approvals and registrations.

(4) the pharmacovigilance system must include a corresponding to its purpose and effective quality system.

(5) the Federal Office for security in the health care sector has carry out regular audits of pharmacovigilance system of medicinal products for human and in no later than 21 September 2013 and then to report to the Commission every two years.

(6) the Federal Office for security in healthcare has the Agency and the Commission at least 24 hours prior to a public announcement regarding to inform pharmacovigilance concerns in relation to the application of a pharmaceutical speciality, unless that immediate public releases are required for the protection of public health.

section 75c. (1) the Federal Office for security in the health care sector has under the pharmacovigilance system to ensure that the following information on the Internet portal for medicines (§ 27) will be published: 1 important information about concern from pharmacovigilance, relating to the use of a medicinal product; These are promptly to provide the public, this way to remove all personal information or confidential information are commercial, unless its disclosure is necessary to protect of public health; before publication, the authorisation or registration holder is, where appropriate, to hear;

2. summaries of the risk management plan of each medicinal;

3. the list of medicinal products according to article 23 of Regulation (EC) No. 726/2004 and 4 information about the different ways for reporting suspected adverse reactions by health professionals and patients including Internet forms provided for this purpose.

(2) a publication referred to in paragraph 1 Z 1 affected can a review of the legality of the publication in a administrative decision to be processes at the Federal Office for security in the health service request. The Federal Agency has known initiation of such proceedings in the same way in this case to make. Is the illegality of the publication is determined in a review, so the Federal Agency to suspend the publication or to revoke either at the request of the person concerned or to remove from the Internet portal has."

46. the previous sections 75 d to 75f received the designation "75n" to "75", following §§ 75 d inserted up to 75 m:

"§ 75 d. (1) the Federal Office for security in the health care sector has all suspected adverse reactions which have occurred in Austria and by health professionals or patients to note are brought, to capture. If necessary, the information must be completed in order to track of these messages.


(2) the Federal Office for security in the health care sector has to electronically submit the reports referred to in paragraph 1 on serious suspected adverse reactions within 15 days of their receipt to the Eudravigilanz database. It has to submit the above reports on non-serious suspected adverse reactions within 90 days after receipt in paragraph 1 electronically to the Eudravigilanz database. If necessary, the Federal Agency has to inform the holder of the authorisation.

(3) the Federal Office for security in the health care sector has by application of methods for collecting information and, if necessary, by tracking suspected adverse reaction reports to ensure that all appropriate measures be taken, biological pharmaceuticals, which prescribed, given, sold or applied in Austria and about their suspected adverse reactions reports are available to identify where the name of the medicinal and batch number are found clearly in accordance with a regulation according to § 26 para 8.

(4) the Federal Office for security in the health care sector has to submit reports on suspected adverse reactions as a result of an error in the application of a medicinal product to the Eudravigilanz database and to make this information available to all the institutions and authorities responsible for patient safety in Austria.

(5) the Federal Office for security in the health care sector has to cooperate with the Agency and the marketing authorisation holders with regard to the discovery of double-counting of reports of suspected adverse reactions.

§ 75e. (1) the Federal Office for security in the health care sector has in cooperation with the Agency to take the following measures: 1. monitors the results of the measures to the Riskenminimierung, which are part of the risk management plans, and the terms and conditions according to § 18 para 3, 19 para 4 and 19b paragraphs 1 and 2, 2. judged's updating of the risk management system, 3. evaluates the data in the Eudravigilanz database's , to determine whether there are new or changed risks and whether the risk-benefit balance is affected by drugs.

(2) the Federal Office for security in the health care sector must inform concerned marketing authorisation holder and the Agency, if recognized, that there are new or changed risks or that the benefit risk balance of medicinal products has changed.

Pharmakovigilanzinspektionen

§ 75f. (1) periodically to check operations in accordance with article 62, paragraph 1, and of these with Pharmakovigilanzaufgaben officers in relation to compliance with the obligations of this section has the Federal Office for security in healthcare.

(2) § 68 para 1 to 3 shall apply mutatis mutandis.

(3) on each Pharmakovigilanzinspektion a transcript in accordance with §§ 14f AVG is to record, is to bring the holder of the authorisation from the Federal Office for security in health care the content of note.

(4) the Pharmakovigilanzinspektion leads to the result that the marketing authorisation holder will not meet the requirements of this section, the Federal Office for security in the health care sector has to rearrange their remedies with notice the holder of the authorisation after obtaining an opinion to the identified deficiencies. Is the fix order of lack of not complied with, the Federal Agency has to take measures according to article 23.

(5) in cases of paragraph 4, the Federal Office for security in the health care sector has to inform the Agency, the Commission and the other Member States of the Union, provided that it concerns human medicinal products.

(6) the Federal Office for security in the health care sector has performed inspections in accordance with the guidelines of the Commission according to article 111a of Directive 2001/83/EC and thereby cooperate with the Agency through exchange of information on planned and carried out inspections.

Duties of health professionals

§ 75 g. (1) doctors, dentists, veterinary surgeons, dentist, midwives and, as far as they are subject to not the notification according to § 75j, pharmacist and producers who are entitled and have druggist pursuant to the Gewerbeordnung 1994 to the manufacture of medicinal products or wholesale trade in medicines suspected 1 side effects or 2nd suspected adverse reactions in humans or 3. the lack of expected efficacy or 4 not sufficient latency of medicines that have occurred in Germany and them on the basis of their professional activity are known , in accordance with a regulation in accordance with § 75a immediately to report the Federal Office for security in healthcare.

(2) the notifying parties referred to in paragraph 1 have to inform the Federal Office for security in the healthcare sector all observations and data, which might be important drug safety.

§ 75 h. Persons who g and 75j subject to §§ 75 not notification, in particular patients, have the ability to report suspected adverse reactions to medicinal products the Federal Office for security in healthcare via the Internet portal for medicines or by mail.

Obligations of the holder of the approval

Pharmacovigilance system

§ 75i. (1) the holder of the authorisation of a medicine specialty has to operate a pharmacovigilance system for its medicinal.

(2) in the framework of the pharmacovigilance system the holder of the authorisation 1. permanently and continuously from a suitably qualified person responsible for pharmacovigilance must (Pharmakovigilanzverantwortlicher), cause 2 a pharmacovigilance system master file and make them prompted the Federal Office of security in the healthcare system at any time within seven days available, 3. a risk management system a) for any individual human medicinal and b) for an animal medicine specialty, if necessary with regard to the identified and potential risks of the medicinal , 4. the results of actions to the Riskenminimierung monitor, which are part of the risk management plan, or in accordance with the § 18 para 3, 19 have been written above para. 4 and 19 b of paragraph 1 and 2 as terms or conditions of approval, updating of the risk management system make 5th and pharmacovigilance data monitor 6, to determine whether there are new risks, existing risks have changed, or the benefit risk balance of medicinal products has changed.

(3) the marketing authorisation holder must scientifically evaluate all information within the framework of the pharmacovigilance system, examine possibilities of Riskenminimierung and prevention and, if necessary, appropriate measures.

(4) the authorisation holder is obliged to undergo his pharmacovigilance system of regular audits. The main findings of the audit are to be noted in his pharmacovigilance system master file. According to the audit results, he has to work out an action plan to remedy the defect and to follow them. If the measures taken to remedy the defect are completely performed, the endorsement of the pharmacovigilance system master file can be deleted.

(5) the Pharmakovigilanzverantwortliche must be resident in the European economic area and active and has to set up the system of pharmacovigilance and lead. The marketing authorisation holder has to notify the Federal Office for security in the health sector and the Agency name and the contact details of the Pharmakovigilanzverantwortlichen, and any modification of this data immediately.

(6) without prejudice to paragraph 5, the Federal Office for security in health care may require the designation of a contact person for Pharmakovigilanzfragen in Austria which reports to the Pharmakovigilanzverantwortlichen.

(7) significant changes of significance for the safety of the medicinal information in labelling, trade or use information, be carried out on the basis of reports of side effects of the marketing authorisation holder has to put the users and pharmacists immediately thereof.

(8) the marketing authorisation holder known to do in connection with its approved medicinal no pharmacovigilance information without prior or simultaneous notification to the Federal Office for security in the health service, the Agency and the Commission publicly. The marketing authorisation holder has to ensure that such public announcements are objective and not misleading.

Capturing and reporting suspected side effects

§ 75j. (1) the marketing authorisation holder has to capture suspected adverse reactions that have occurred in the European economic area, and in third countries. Furthermore any suspected transmission of infectious agents through a medical specialty, which occurred in a third country is to capture.

(2) the marketing authorisation holder must ensure that the information is available under para 1 anywhere in the European economic area. He may not refuse the acceptance and testing of messages from health-care professionals and patients.

(3) the marketing authorisation holder has details of all suspected serious adverse reactions that have occurred in the European economic area, and in third countries, has 15 days after he becomes aware of it, to submit electronically to the Eudravigilanz database. Information about all suspected non-serious adverse reactions that have occurred in the European economic area, the holder of the authorisation, within 90 days, after he has become aware of which has to submit electronically to the Eudravigilanz database.


(4) in the case of medicinal products containing active substances, the list of publications refers, that monitored the Agency in accordance with article 27 of Regulation (EC) No. 726/2004, the marketing authorisation holder are not obliged to send the suspected adverse reactions listed in the medical literature that is listed in the list, to the Eudravigilanz database.

(5) the marketing authorisation holder is obliged to introduce procedures by the accurate and verifiable data for the scientific evaluation of reports of suspected adverse reactions can be won. He must collect information in order to track these messages and submit the updated information to the Eudravigilanz database.

(6) the authorisation holder shall be required to cooperate with the Agency and the Federal Office for security in the health sector with regard to the discovery of double-counting of reports of suspected adverse reactions.

(7) the holder of the authorisation has regularly the messages under section to find out about 75 g in the ways of the Eudravigilanz database.

(8) the Federal Office for security in the health care sector has to impose only additional obligations on reporting suspected side effects to the holder of the authorisation, if this is necessary for pharmacovigilance reasons.

Regularly updated report on the safety of medicinal products (PSUR)

§ 75 k. (1) the marketing authorisation holder is obliged to deliver the regularly updated reports on the safety of medicinal products to the data archive for the regularly updated reports electronically. These must include the following: 1 summaries of data, which are for the assessment of the benefits and the risks of a pharmaceutical speciality of interest, including the results of all studies that have potential impact on the admission, 2. a scientific assessment of the risk-benefit balance of medicinal and 3rd all data relating to the volume of sales of the medicinal as well as all him present data in connection with the volume of prescriptions , including an estimate of the number of people who apply the medicine specialty.

The evaluation must be based after no. 2 on all available data, including data from clinical trials for application areas and population groups which are not approval.

(2) by way of derogation from paragraph 1 the marketing authorisation holder with an approved as generic or § 10a and the holder of the registration as traditional herbal medicinal periodic updated safety reports only transmit to the data archive for the regularly updated reports if 1 such a commitment as a condition or requirement for the grant was written before the authorisation or registration or 2. must a template by the Federal Office for security in health care because of concerns in connection with pharmacovigilance data or due to concerns over the lack of regular updated reports on the safety is ordered by medicinal products for an active ingredient after authorisation or registration.

(3) the Federal Office for security in the health care sector has to prescribe in the notice of admission, in which rhythm the periodic updated safety reports are to be submitted. The deadline for the submission is calculated as according to the prescribed rhythm from the legal force of the approval notification.

(4) the holder of the authorisation, whose medicinal before the entry into force of this federal law in the version of Federal Law Gazette I no. 110/2012 has been approved, and for the submission of term date for the regular update reports on the safety of medicinal products not in terms of decision was fixed, shall submit the periodic safety update report on the safety of medicines following according to the Federal Office for security in healthcare : 1. If the medicinal not yet on the market has been: at least every six months after authorisation, 2. If the medical speciality in traffic has been: at least every six months during the first two years after the first placing on the market, once a year in the next two years, and thereafter at intervals of three years and 3 at any time immediately upon request by the Federal Office for security in healthcare.

The requirements apply to Nos. 1 and 2 until in a change of the approval or in accordance with subsection 6 or 7 a different rhythm or other template dates have been set.

(5) section 4 applies to the medicinal products which are allowed only in Austria and do not fall under paragraph 6.

(6) for medicinal products, which contain the same active ingredient or the same combination of active ingredients, but are subject to various approvals, and where the rhythm and the dates for the submission of the periodic safety update report on the safety of medicinal products harmonised what was publicly disclosed by the Agency on the European Internet portal for medicines, concerned marketing authorisation holder must report the change of approval the Federal Office for security in healthcare. Changes of admission are to bring into force six months after publication.

(7) authorisation holder may for the following reasons at the Committee for human medicinal pursuant to article 5 of Regulation (EC) No. 726 / 2004 or the coordination group pursuant to article 27 of Directive 2001/83/EC apply that set a deadline in the Union or changed the rhythm of the template of regular updated reports on the safety of medicinal products: 1. for reasons of public health, 2. to avoid double assessment or 3. with regard to international harmonisation.

Such applications must be in writing and justified. Any change of dates or the rhythm of the template of regular updated reports on the safety of medicines will be publicly announced by the Agency on the European Internet portal for medicines. Concerned marketing authorisation holder must report the change of registration the Federal Office for security in healthcare. Changes of admission are to bring into force six months after publication.

§ 75 l. After examination and assessment of the regular updated report on the safety of medicinal products in terms of a modified risk-benefit balance is the Federal Office for security in health care according to the extent of any existing risk, if necessary, impose requirements or has to waive the admission or dormant to put them. This applies also in the case of a uniform assessment under article 107e of Directive 2001/83/EC.

§ 75 m. Marketing authorisation holder are required to inform the Federal Office for security in the health care sector and the Agency, if there are new or changed risks or if recognized, that the benefit risk balance of medicinal products has changed."

47. 75n para 3 (new) paragraph:

"(3) the head of a blood banks within the meaning of § 8f KAKuG and the respective implementing regulations or, where one does not exist, the Medical Director of the hospital and physicians including group practices are committed to serious incidents that can occur and affect the quality and safety, storage or distribution of blood and blood components, as well as serious adverse reactions that occur during or after the transfusion and can be attributed to the quality and safety of blood and blood components ", reported it immediately to the Federal Office for security in the health care sector."

48. According to § 75 75q the following paragraph with heading shall be inserted:

"Quality defects

§ 75q. (1) quality defects are 1 defects within the meaning of section 4 and is a danger to life or health of humans or animals to get 2. shortcomings of marketed medicinal trade packs, composition or nature, if this.

(2) physicians, dentists, veterinary surgeons, dentist, midwives receive and, as far as they are subject to no notification pursuant to § 75j, pharmacists and producers who are entitled, pursuant to the Gewerbeordnung 1994 to the manufacture of medicinal products or to the wholesale of medicines and druggist on the basis of their professional activity so have details of quality defects that have occurred in the country immediately to inform them about the Federal Office for security in healthcare.

(3) the marketing authorisation holder has immediately to report at the latest within 15 days after the announcement, quality defects, which occurred domestically and were brought to him pursuant to par. 2 note or otherwise note arrived, to capture and the Federal Office for security in healthcare. The marketing authorisation holder has the original wording the relevant communication to document and to keep five years and immediately to deliver the Federal Office for security in the healthcare sector at the request he filed.

(4) if due to the lack of quality a direct danger to life or serious and substantial danger to health is to get the message to the Federal Office for security in the health care sector must be done immediately.


(5) paragraphs 1 to 4 apply by analogy to the holder of the registration as their own pharmacy or homeopathic medicinal.

(6) paragraphs 1 to 4 shall apply by analogy to the holder of an authorisation for distribution in the parallel import. Also has an authorisation of distribution in the parallel import holder within the period to inform the marketing authorisation holder or the holder of the registration as their own pharmacy or traditional herbal medicinal about this message.

(7) is a significant risk to public health, due to the lack of quality the Federal Office for security in the healthcare sector delivered a quick warning all other Member States of the European economic area and all potential actors in the supply chain in the country. There is the reasonable suspicion that an immediate threat to life or serious and substantial danger to health to get is, as the Federal Office for security in healthcare has immediately, at the latest however within 24 hours informing of the public about the lack of quality and the dangers it posed to make is to assume that patients has already reached the medicinal Any measures already taken by the holder of the authorisation are taking into account. paragraph 2 shall apply mutatis mutandis. § 75 c"

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

"§ 77. Is detected during an inspection under section 76 or the Federal Agency becomes aware that a medicinal product or active ingredient of this federal law or regulations adopted on the basis of this Federal Act, or other administrative acts does not meet, for safety in health care otherwise, assumes the Federal Office for security in the health care sector has to have measures that prevent the placing on the market or restrict. If necessary, section 76 is to apply (b) paragraph 10.

78. (1) the Federal Office for security in healthcare come facts to note is that a medicinal product in the traffic or active ingredient represents a danger to life or health of humans or animals on the basis of which to get, has all the necessary measures to have the Federal Office for security in health care according to the extent of the risk, which hinder the placing on the market of the medicinal product or active substance or the use of the medicinal product or restrict.

(2) measures referred to in paragraph 1 may be taken 1 even without previous procedures or 2 ago adopted a notice in the case of danger in delay by a drug or a drug.

In the case who is no. 2 but a period of two weeks by the Federal Office for safety in health care a written opinion to adopt, failing which the taken measures lifted considered.

(3) the Federal Office for security in the health care sector has to explain the medicines seized by him or the seized drug as a precautionary measure revoked if a serious and significant threat posed by him human or animal, and the claimant does not warrant that the medicinal product or the active substance is placed after its release not in traffic.

Provisional seizure

§ 78a. Organs of the Federal Office for security in the healthcare sector have to seize medicinal products or active substances if there is reasonable suspicion, that this 1. contrary to the provisions of this Federal Act or fact based regulations or other administrative acts in traffic are brought and represents a threat to the life or health of humans or animals 2. provisionally, taking into consideration the protection objectives of this Federal Act.

The provisions of § apply 76b of the provisional seizure by supervisory bodies and measures the district administrative authorities in the administrative criminal proceedings, as well as § 76 c."

50 § 83 para 1 No. 13 and 14 is: "13 as the marketing authorisation holder, holder of the registration or the marketing authorisation holder in the parallel imports to IX section or § 94 h not fulfil its obligations, or 14 violated the reporting obligations pursuant to § 75 g or § 75n," 51. § 84a replaces the year "2002" with the year "2010".

52. Article 85a para 3 is as follows:

"(3) is the origin of the infringement within the meaning of paragraph 1 in Austria, so the claim of each can para 3 of Directive 2009/22/EC of 23 April 2009 on injunctions for the protection of consumer interests, OJ in the official journal of the European Union by the Commission in accordance with article 4 No. L 110 of May 1, 2009 p. 30, published authorities and organizations of another Member State of the European Union claimed, provided that 1 the interests protected by that institution in that Member State are affected and the purpose of the institution specified in the publication of this litigation justifies 2.."

53. § 86 para 4 No. 13 is: "13 the design protection law of 1990, Federal Law Gazette No. 479/1990," 54. § 86 para 4 Z 18 is: "18 the new psycho-active substances Act, Federal Law Gazette I no. 146/2011," 55. § 94a, paragraph 6 reads:

"(6) substances or preparations from substances in the sense of § 1 para 3 Z may be 8 provided this in advance always in the same composition are produced and placed under the same name in a form specific to the levy in the retail market that pursuant to section 11 (b) in the version of Federal Law Gazette No. 748/1988 were reported, up given the expiry of 31 December 2013 further inland or kept ready for delivery in Germany ", unless it is section 3, which applies to these products prevent."

56. Article 94b, second sentence, is eliminated.

57. According to § 94 g the following section is inserted 94 h including heading:

"Transition law amendment to the Act Federal Law Gazette I no. 110/2012"

§ 94 h. (1) Article 9a, paragraph 1 Z 22 as amended by Federal Law Gazette I no. 110/2012 does not apply to authorisations or registrations of pharmaceutical specialties, I no. 110/2012 were applied prior to the entry into force of this federal law in the version of Federal Law Gazette.

(2) Article 9a, paragraph 1 Z 34 as amended by Federal Law Gazette I no. 110/2012 does not apply to authorisations or registrations of human medicinal I no. 110/2012 were applied prior to the entry into force of this federal law in the version of Federal Law Gazette. In these cases the marketing authorisation holder or holder of the registration the obligation to conduct a pharmacovigilance system master file from the legal force of the extension of the authorisation or registration, have no later than 21 July 2015, to meet.

(3) the professional and use information of medicinal products, before the entry into force of this federal law in the version of Federal Law Gazette I no. 110/2012 approved or registered, Z 13 and 16 para 2 have the sections 15 para 2 No. 19 to the date immediately possible, but no later than three months after the designation on the list referred to in article 23 of Regulation (EC) No. 726 / 2004 , to meet.

(4) the technical and use information of medicinal products, before the entry into force of this federal law in the version of Federal Law Gazette I no. 110/2012 approved or registered, no. of 14 and 16 para 2 have the sections 15 para 2 Z 20 immediately possible when, at the latest however with 1.  July 2014 to comply with.

(5) serves the change of a specialist or use information of only the adjustment according to paragraph 3 or 4, which change by the holder of the authorisation or the holder of the registration is to sign the Federal Office for security in healthcare.

(6) section 20 para 2 as amended by Federal Law Gazette I no. 110/2012 applies to medicinal products which approval or registration would end after 21 April 2013.

(7) the sections 75a para 3 and 4 and 75 b in the version before the amendment to the Federal Law Gazette apply for veterinary medicinal products I no. 110/2012.

(8) the sections 75a para 3 and 4 and 75 b in the version before the amendment to the Federal Law Gazette apply registered their own pharmacy medicinal I no. 110/2012.

(9) § 75b paragraphs 1 and 2 in the version before the amendment to the Federal Law Gazette I no. 110/2012 mutatis mutandis also applies to the holder of an authorisation for distribution in the parallel import. A message is regarding a medical specialty that was spent on the basis of a permit for the distribution in the parallel import to Austria, according to § 75 g so the Federal Office for security in healthcare has the holder of the permit for the distribution in the parallel import without delay, but no later than 15 days after the announcement, to inform. The information must be done in an anonymous form.


(10) § 75j para 3 as amended by Federal Law Gazette I no. 110/2012 occurs six months after notification of the Agency on its Web portal, the Eudravigilanz database has the appropriate capabilities in force. Until then, § 75j para 3 with the proviso that the messages to the Federal Office for security in health care have to be taken and all suspected non-serious side effects of immunological medicinal products and medicinal products which are manufactured from human blood or plasma as a starting material using medicinal products that are on the list referred to in article 23 of Regulation (EC) No. 726/2004 applies , which have occurred within 90 days of the holder of the authorisation of which has become aware in Austria, are to report to the Federal Office for security in healthcare.

(11) section 75 k para 1 and 2 in the version of Federal Law Gazette I no. 110/2012 regarding the commitment to the electronic delivery of regularly updated reports on the safety of pharmaceutical products 12 months after notification of the Agency on its Web portal, that has the data archive for the regularly updated safety reports on the corresponding functions, enter into force. Until then, the periodic safety update report on the safety of medicines are to submit the Federal Office for security in healthcare.

(12) the Federal Office for security in the health care sector has to inform the Commission until 22 July 2013 over the details of the system according to article 75, paragraph 3."

58. the point is replaced at the end of article 97 Z 28 by a comma, following Z 29 is appended: "29 directive 2010/84/EC of the European Parliament and of the Council of December 15, 2010, to amend Directive 2001/83/EC establishing a Community code relating to human medicinal products with regard to the pharmacovigilance, OJ" No. L 348 of December 31, 2010, S 74, as amended by the amending OJ No. L 21 of 25 January 2011, S 8."

Fischer

Faymann