79. Federal Act on the Import and Introduction Of Medicinal Products, Blood Products and Products of Natural Medicinal Products (Proprietary Medicinal Products Import Act 2010-AWEG 2010)

The National Council has decided:

Section 1

Scope and definitions

Scope

§ 1. (1) This federal law shall apply to the importation and the introduction of medicinal products and blood products. This federal law also applies to the import of products of natural healing resources.

(2) This federal law does not apply to the importation and the movement of goods that are used as medical devices according to the Medical Devices Act, BGBl. No 657/1996.

Definitions

§ 2. In the sense of this federal law means:

1.		The following products within the meaning of Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff, OJ L 327, 30.4.1987, p. No. OJ L 256 of 07. 09. 1987, S 1:
a)			Goods of subheading 3002 20,
b)			Goods of subheading 3002 30,
c)			Goods of heading No 3004,
d)			X-ray contrast media and diagnostic reagents for internal use in patients from subheading 3006 30,
e)			Goods of subheading 3006 60, and
f)			Wetting liquids for hard contact lenses and care products for soft contact lenses from subheading 3307 90;
2.		Blood products: the following products within the meaning of Regulation (EEC) No 2658/87:
a)			Placents from subnumber 3001 90, and
b)			Goods of subheadings 3002 10 and 3002 9010;
3.		Products of natural healing resources: goods falling within subheadings 2201 10, ex 2201 90, ex 2501 00, ex 2530 90, ex 3003 90 and 3004 90 within the meaning of Regulation (EEC) No 2658/87;
4.		Imports: transport of medicinal products, blood products or products of natural medicinal products from non-Contracting Parties to the European Economic Area (EEA), into the territory of the Federal Republic, with the exception of the verifiable transit;
5.		spend: transport of medicinal products or blood products from a Contracting Party of the EEA to the Federal Republic, with the exception of the proven transit;
6.		Distance sales: conclusion of a contract with the exclusive use of one or more means of distance communication;
7.		Means of distance communication: means of communication which may be used for the conclusion of a contract without the simultaneous physical presence of the parties, in particular printed matter with or without address, catalogues, press releases with order form, pre-manufactured standard letters, long-distance calls with persons or vending machines as interlocutors, radio, videophone, teletopia, teleshopping as well as publicly accessible electronic media, which allow individual communication, such as the Internet or the electronic mail.

Section 2

Medicinal products

Import, Bringing, Authority

§ 3. (1) The importation or the placing of medicinal products in doses or in presentation for retail sale, unless otherwise specified by this Federal Act, shall only be permitted if an import certificate has been issued in the case of importation or, in the case of importation, the introduction of a message has been made.

(2) The Federal Office for Safety in Health Care is responsible for issuing import certificates and receiving notifications.

Application and notification authority

§ 4. (1) In order to apply for the issue of an import certificate and for the notification, the following shall be entitled:

1.		public pharmacies,
2.		Event pharmacies, and
3.		Undertakings authorised to distribute medicinal products in a Contracting Party to the EEA.

(2) Applications for the issue of a certificate of import or notifications shall be submitted, provided that they are not in electronic form in accordance with a regulation in accordance with § 81a of the German Medicines Act (BGBl). No 185/1983, should be submitted using the appropriate forms to be published on its website by the Federal Office for Health and Safety in the Health Care Sector.

(3) Applications for the issue of an import certificate shall contain all the information necessary for the assessment of the import, in particular those provided for in Article 5 (1), (2) and (4).

(4) Only hospital-leading veterinarians are entitled to report in accordance with Section 9 (1).

Import certificate

§ 5. (1) An import certificate in accordance with § 3 may only be issued for medicinal products which:

1.		are intended for re-export from the territory of the Federal Republic of Germany; or
2.		for scientific purposes are not intended for use in humans or animals, or
3.		for use in humans or animals for medical, dental, veterinary or scientific purposes.

(2) In the case of paragraph 1 (1) (3) for proprietary medicinal products, the import certificate may only be issued if it is

1.		are intended for clinical or non-clinical trials or clinical trials, or
2.		necessary for medical, dental or veterinary treatment, because the success of treatment with a proprietary medicinal product approved and available in Austria is not likely to be achieved.

(3) An import certificate shall be issued only if there are no objections to the importation of the medicinal products in question on health grounds.

(4) A medical, dental or veterinary opinion shall be attached to an application for the issue of an import certificate in accordance with paragraph 2 (2) (2) of the EC concerning the existence of the conditions provided by the doctor, dentist or veterinarian who shall: Medicinal speciality required.

(5) If the respective conditions for an import pursuant to para. 1 to 4 do not exist, the Federal Office for Safety in the Health Care must reject the application with a decision or, if necessary, under the terms of such conditions, to issue such conditions, the performance of which shall ensure the quality of the medicinal products necessary for the protection of human or animal health and life.

Message

§ 6. (1) The placing of medicinal products authorised or manufactured in a Contracting Party of the EEA may be effected only for the purposes of Article 5 (1) and (2) and shall require a notification in accordance with § 3.

(2) In the case of medicinal products for clinical or non-clinical trials or clinical trials which have been manufactured in Switzerland and are transported to Austria from Switzerland, it is also necessary to report only.

(3) A notification as referred to in paragraphs 1 and 2 shall be made no later than two months after the date of the installation.

(4) The report shall contain:

1.		the name and quantity of the medicinal products used,
2.		details of the more specific purpose,
3.		where appropriate, an opinion on the existence of the conditions laid down in § 5 (2) (2) (2) by the doctor, dentist or veterinarian who requires the proprietary medicinal product; and
4.		the package leaflet.

(5) In the case of re-export, the target State shall be designated, in the case of clinical trials, the test centres for which the medicinal product in question is intended.

(6) Para. 1 to 5 shall not apply to the movement of medicinal products in accordance with § § 7, 8 and 9.

Special reports

§ 7. (1) The movement of immunological medicinal products for human use, which shall:

1.		are authorised in a Contracting Party to the EEA; and
2.		required for the implementation of vaccinations recommended in the Austrian vaccination plan to bridge delivery bottlenecks,
requires a notification to the Federal Office for Safety in Health.

(2) The notification shall be made at least three weeks before being sent to the territory of the Federal Republic of Germany.

(3) The Federal Office for Security in the Health Service shall not be responsible for the failure if the conditions set out in paragraph 1 are not fulfilled.

(4) In the course of three weeks after the notification has been received in the Federal Office for Health and Safety in the health care sector, no undersac shall be deemed to have been granted, the case shall be deemed to be granted.

(5) The notification referred to in paragraph 1 shall be:

1.		the description and quantity of the immunological medicinal product for human use to be introduced,
2.		their batch number, and
3.		the package leaflet
to be included.

§ 8. (1) The movement of immunological veterinary medicinal products which:

1.		are authorised in a Contracting Party to the EEA; and
2.		which are necessary for the prevention or prevention of the proliferation of epizootic diseases or diseases, since in Austria no immunological veterinary medicinal product is authorised against the animal disease or disease in question for the particular species of animal and available,
requires a notification to the Federal Office for Safety in Health.

(2) The notification shall be made at least six weeks before the date of referral, the notification being accompanied by a veterinarian opinion of a veterinarian on the existence of the conditions set out in paragraph 1 (2).

(3) The Federal Office for Safety in Health shall not be responsible for the failure to comply with the conditions laid down in paragraph 1 or in respect of immunological veterinary medicinal products listed in § 12 of the Animal Health Act (RGBl). No 177/1909, no application of the application, or a Regulation on the temporary application of the Regulation.

(4) In the course of six weeks after the notification has been received in the Federal Office for Health and Safety in the health care sector, no undersac shall be deemed to have been granted, the case shall be deemed to be granted.

(5) The notification referred to in paragraph 1 shall be:

1.		the name and quantity of the immunological veterinary speciality to be introduced;
2.		their batch number,
3.		the package leaflet, and
4.		Details of the specific purpose of the relevant import
to be included.

§ 9. (1) The transfer of veterinary medicinal products by hospital-leading veterinarians for their own consumption (including the levy in the context of a permanent care ratio within the meaning of § 24 para. 3 of the Veterinary Act, BGBl. No 16/1975, or § 7 of the Veterinary Medicinal Products Control Act, BGBl. I No 28/2002),

1.		in the case of veterinary medicinal products within the meaning of Article 5 (2) (2), a Contracting Party to the EEA, or
2.		in the case of veterinary medicinal products which are authorised in a Contracting Party of the European Economic Area and comply with authorised veterinary medicinal products in the territory of the Federal Republic of Germany, by way of derogation from the provisions referred to in § 10c of the medicinal products
A report to the Federal Office for Safety in Health Care.

(2) A veterinary speciality shall be equivalent to a veterinary speciality already authorised within the meaning of paragraph 1 (2), if it

1.		has the same origin as the veterinary speciality already authorised, when it was produced by the same undertaking, a related undertaking or under the same procedure as the licence,
2.		contains the same active substances with approximately the same degree of efficiency and with a corresponding minimum degree of degree of intolerance, no therapeutically relevant deviations are to be expected; and
3.		otherwise, except in the case of human and animal health or the environment or agricultural or agricultural products, other than those which do not appear to be harmless, and labelling other than those which are not acceptable to the public The trade name and the marketing authorisation holder and suitability of the packaging shall be the same.

(3) The notification pursuant to Section 1 (1) (1) shall be made subject to the application of Section 5 (4). In the case referred to in paragraph 1 (1) (2), the notification shall contain a declaration that the veterinary medicinal product to be placed on the territory of the Federal Republic of Germany and placed on the market there shall be subject to a specific veterinary speciality authorised in the Federal Republic of Germany , the batch number, as well as the intended identification and use information, if a charge is provided within the framework of a permanent care relationship within the meaning of Section 24 (3) of the Tierärztegesetz, or § 7 of the Veterinary Medicinal Products Control Act.

(4) The notification referred to in paragraph 1 shall be made at least two weeks before the date of the application. The Federal Office for Health and Safety (Bundesamt für Sicherheit im Healthcare) is not responsible for the situation if the conditions are not met. If there is no failure within two weeks after the notification has been received in the Federal Office for Health Security, the marketing of the veterinary speciality shall be deemed to be granted.

(5) The provisions relating to waiting periods shall be determined in accordance with the provisions of the authorisation rules concerning the waiting period for veterinary speciality authorised in Austria.

Follow-up duties and verifications

§ 10. (1) In the case of a transport of medicinal products in the context of importation in accordance with § 3, a copy of the import certificate shall be carried along with the inspection bodies at the request of the inspection bodies.

(2) In the case of a transport of medicinal products within the scope of the introduction, proof of the notification made shall be carried out in accordance with § 7 (1), § 8 (1) or § 9 (1) and must be presented to the control bodies on request.

(3) The company and the pharmacy establishment pursuant to Article 4 (1) shall keep records which must contain a detailed documentation of the import or the introduction and the ordering process. In particular, the records shall contain the following information:

1.		the name of the medicinal product, the marketing authorisation holder and the batch number,
2.		the number of commercial packs, indicating the size of the package,
3.		the State from which the medicinal product has been imported or has been introduced, and the supplier established there,
4.		the price to which the medicinal product was obtained, and
5.		Recipient of the medicinal product.
These records shall be kept for at least five years in the company or in the pharmacy establishment and shall be kept ready for review by bodies of the Federal Office for Health and Safety in the healthcare sector or by experts appointed by the Federal Office.

(4) The Federal Office for Health Security may also serve the customs authorities with regard to the verifications referred to in paragraph 3 and section 11 (5), insofar as this serves the appropriate, simple and cost-saving implementation of these controls. and the institutions concerned are adequately trained.

Exceptions

§ 11. (1) § § 3 to 10 shall not apply to:

1.		Proprietary medicinal products which are introduced or introduced and which are demonstrated to be in accordance with Article 7 of the Medicinal Products Act or Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and Monitoring of medicinal products for human and veterinary use and setting up a European Medicines Agency, OJ L 327, 28.4.2002, No. 1. or registered in accordance with § 27 of the Medicines Act or approved in accordance with § 10c of the Medicines Act for distribution in parallel import,
2.		Medicinal products which are imported or brought in and which do not require authorisation pursuant to Article 8 (1) (2) to (5) of the Medicines Act,
3.		Medicinal products which are introduced or introduced and which are not subject to authorisation in accordance with Article 8a (1) of the Medicines Act,
4.		veterinary medicinal products which, in accordance with Article 4a (5) of the Tierärztegesetz, are transferred to the territory of a contracting party to the EEA for the purpose of carrying out the veterinary profession,
5.		Medicinal products which demonstrate that they are introduced or spent in the implementation of emergency relief operations,
6.		Medicinal products imported or transported on entry in a quantity corresponding to the usual personal needs of the traveller or the need for a travelling animal,
7.		Medicinal products for use in human beings, which are obtained in a quantity corresponding to the usual personal needs of the recipient from a contracting party to the EEA where they may be placed on the market,
8.		Medicinal products which are imported or transported and which are intended for the personal use of scientific institutes or investigative bodies of local authorities and of universities, or of the Austrian Agency for Health and food security, but are not intended for human or animal use,
9.		Medicinal products which are imported or brought in and from an eligible person within the meaning of Section 9 of the Medicinal Products Act in small quantities as a sample of a proprietary medicinal product or a substance sample within the meaning of Article 9a (1) (14) of the Pharmaceuticals Act, for the quality control of proprietary medicinal products manufactured abroad under licence of Austrian companies, for the analysis in the context of complaints or in connection with the maintenance of well-known rights ,
10.		medicinal products which are imported or transported and which are required by a marketing authorisation holder to submit a batch test in accordance with Article 26 of the Medicines Act,
11.		medicinal products which are imported or transported and which are required by local authorities to fulfil the tasks assigned to them in accordance with Article 57 (1) (1) (5) of the Medicines Act;
12.		Medicinal products imported into or brought into the territory of the Federal Republic of Germany and imported into the customs territory of the Community pursuant to Title I of Regulation (EEC) No 918/83 on the Community system of exemption from customs duties, OJ L 327, 18.3.1983, p. No. OJ L 105 of 23. 04. 1983, which would remain free of import duties,
13.		Medicinal products imported or imported for use during their stay in Austria for the head of the head or a member of a government of an external State or its accompanying person,
14.		Proprietary medicinal products which are introduced or brought into use and which are used for personal use by members of a diplomatic mission or consular post in Austria or by members of the family, or by members of the staff. Staff of international organisations established in Austria and members of their families, in so far as they are not Austrian nationals,
15.		medicinal products which are exported from the territory of the Federal Republic to another State and which are introduced or introduced into the territory of the Federal Republic of Germany unchanged within a period of one month,
16.		Products which are imported or transported and which are required by the Federal Army's medical service for the purpose of carrying out its duties if they are not available in the same composition, quality and durability at home,
17.		-proprietary medicinal products sent from abroad solely for the personal needs of travellers who do not have their habitual residence in Austria (Section 4 (2) (8) of the Customs Law Implementing Act-ZollR-DG) in Austria for the duration of the stay in Austria, and
18.		the importation and the introduction of medicated feedingstuffs within the meaning of Article 10 of Directive 90 /167/EEC laying down the conditions for the production, placing on the market and use of medicated feedingstuffs in the Community, OJ L 327, 31.12.90, p. No. OJ No L 92, 7. 04. 1990, provided that the consignment is accompanied by a certificate within the meaning of Annex B to Directive 90 /167/EEC.

(2) The exception provided for in paragraph 1 (1) (6) shall not apply to proprietary medicinal products acquired in another State which are imported or brought into the territory of the Federal Republic by travellers with ordinary residence (Article 4 (1) (8) of the Customs R-DG) in the territory of the Federal Republic of Germany, where the exceeds the amount of three commercial packages of a proprietary medicinal product intended for the supply of private persons.

(3) The reference to proprietary medicinal products within the meaning of Para. 1 Z 7 shall be made via a national public pharmacy. In the case of proprietary medicinal products which are subject to prescription in the EEA Contracting Party from which they are referred, a medical or dental prescription shall be submitted.

(4) The exceptions to paragraph 1 (7) shall not apply where the imported quantity exceeds three commercial packages of a proprietary medicinal product intended for the supply to private persons, unless the transfer is carried out under the following conditions: Domestic public pharmacy:

1.		at the time of introduction into the territory of the Federal Republic of Germany, it shall be established that the proprietary medicinal products are intended for the transfer to certain persons of their personal needs and that the quantity of the medicinal products intended for a person is three for the purpose of surrender to private persons; does not exceed the commercial packaging of a proprietary medicinal product; and
2.		the existence of the conditions of the Z 1 is demonstrated or at least made credible.

(5) In respect of a reference in accordance with paragraph 1 Z 7, the commissioned national public pharmacy shall keep records which must contain a detailed documentation of the handling of the order process and at least the following information:

1.		the name of the proprietary medicinal product,
2.		the number of commercial packs, indicating the size of the package,
3.		A contracting party to the EEA from which the proprietary medicinal product has been obtained and the supply company established there,
4.		the price to which the proprietary medicinal product was obtained,
5.		the recipient of the proprietary medicinal product; and
6.		where appropriate, the name and professional seat of the prescribing physician or dentist.
These records shall be kept for at least five years in pharmacy operations and shall be kept ready for review by bodies of the Federal Office for Health and Safety in the healthcare sector or by experts appointed by the Federal Office.

(6) The purpose of the importation or the placing of medicinal products within the meaning of paragraph 1 (1) (8) to (10) shall be proven or at least to be credible.

(7) The existence of the conditions set out in paragraph 1 Z 17 shall be demonstrated by a copy of the prescription issued to the person concerned by the attending physician or dentist, which clearly indicates the facts of the case, or at least to make it credible.

Section 3

Blood products

Import, certificate of transport capability

§ 12. (1) The importation of blood products, unless otherwise specified in this Federal Act, is only permissible if a certificate of transport capacity has been issued by the Federal Office for Health Security.

(2) A certificate of transport capability shall be issued only if there are no objections to the importation of the blood products concerned on health grounds. Otherwise, the Federal Office for Health and Safety (Bundesamt für Sicherheit im healthcare) must notify the request or, if necessary, to issue such conditions under the name of such conditions, the fulfillment of which is the case for the protection of the health and life of humans. the nature of the medicinal products required.

(3) In the case of imports of blood products for direct transfusion, the ability to transport blood is not in any case given if the donation of blood, apart from the cases in which the donor is based on immediate needs in an acute emergency situation of the blood donation facility has been requested for immediate donation, and has not been paid entirely unpaid. This does not apply if the import is necessary to secure the supply of extremely rare blood groups.

Application authorization

§ 13. (1) In order to apply for an issue of a certificate of transport qualifications, the following shall be entitled:

1.		public pharmacies,
2.		Event pharmacies, and
3.		Undertakings authorised to distribute medicinal products or blood products in a Contracting Party of the EEA.

(2) If they are not to be submitted in electronic form in accordance with a regulation in accordance with § 81a of the German Medicines Act, applications for the issue of a certificate of transport certificate shall be made using the relevant forms, published by the Federal Office for Health Security on its website.

(3) Applications for the issue of a certificate of transport certificate shall contain all the information necessary for the assessment of the import, and the Federal Minister of Health in a Regulation shall lay down more detailed provisions on the subject of the to set up documents to be submitted.

Spending, reporting

§ 14. (1) The placing of blood products shall be subject to a notification to the Federal Office for Health Security, which must be made at least three weeks prior to the placing of the blood.

(2) The following shall be entitled to report:

1.		public pharmacies,
2.		Event pharmacies, and
3.		Undertakings authorised to distribute medicinal products or blood products in a Contracting Party of the EEA.

(3) If they are not to be transmitted in electronic form in accordance with a regulation in accordance with § 81a of the German Medicines Act (Medicines Act), notifications shall be made using the relevant forms provided by the Federal Office for Security in the health care on its website.

(4) The Federal Office for Safety in the Health Care shall be informed of the failure to do so if:

1.		concerns the placing of the blood products concerned on health grounds, or
2.		The blood donation, apart from the cases in which the donor has been requested to donate immediately from the blood donation facility on the basis of immediate needs in an acute emergency situation, has not been paid entirely unpaid. This does not apply if the import is necessary to secure the supply of extremely rare blood groups.

(5) In the course of three weeks after the notification has been received in the Federal Office for Health and Safety in the health care sector, no undersac shall be deemed to have been granted, the case shall be deemed to be granted.

(6) The Federal Minister of Health has to lay down detailed provisions in a regulation with regard to the documents to be submitted in the context of the notification in accordance with paragraphs 1 and 7 of this Regulation.

(7) Where blood products are medicinal products authorised in one of the Contracting Parties to the EEA, the notification to the Federal Office for Safety in the Health Care shall be made no later than two months after the date of the marketing of the medicinal product. ,

Follow-up duties and verifications

§ 15. (1) The person who introduces or spends blood products, or the person for whom the goods are intended, has the Federal Office for Safety in Health or the Federal Office for Safety in Health, or the expert appointed by the Federal Office for Safety in the Health Sector, to provide proof of the quality and Security to be provided. In any case, it is to be proven that in the case of blood products for direct transfusion the donation has been made entirely unpaid, or in cases where the donor is based on immediate needs in an acute emergency situation from the Blood donation facility for immediate donation has been requested, only an immigrant rate has been made.

(2) The documents referred to in paragraph 1 shall be in the holding of the person who imports or spends blood products, or of the person for whom the goods are intended, or it must be ensured by contractual agreement that they shall be the Federal Office of the Federal Republic of Germany. in the case of health security, on the latter's request, to be submitted for review without delay. These records shall be kept for a minimum of five years and shall be kept ready for review by the Federal Office for Health and Safety in the health care sector or by experts appointed by the Federal Office.

(3) In the case of a transport of blood products in the context of importation, the certificate of transport capability shall be carried along and shall be notified to the inspection bodies at the request of the person. In the case of a transport of blood products within the scope of the introduction, proof of the notification has to be carried out and the inspection bodies shall be required to show them on request.

Exceptions

§ 16. § § 12 to 15 do not apply to the importation or the introduction of small quantities of blood products which are not intended for use in human beings solely for the purpose of quality control, analysis or scientific purposes.

Section 4

Remote offset

Reference to medicinal products and blood products in distance marketing

§ 17. (1) The reference to medicinal products and blood products ordered at a distance from persons who are not entitled to apply for the issue of an import certificate or a certificate of transport certificate or to be notified shall be subject to the following conditions: forbidden.

(2) Medicinal products and blood products which are imported or brought into breach of the provisions of paragraph 1 shall be returned to the sender or, if this is not possible, to destroy them. The costs for this shall be borne by the customer.

(3) Paragraph 1 shall not apply to proprietary medicinal products which are not authorised in Austria and which are obtained in a quantity corresponding to the usual personal requirements from a contracting party of the EEA from a pharmacy authorized there for dispatch.

Section 5

Natural healing products

Import certificate

§ 18. (1) The importation of natural medicinal products, if they are to be placed on the market in the country under the guidance of medical indications, shall be permitted only if an import certificate has been issued for that purpose.

(2) The Federal Office for Safety in Health is responsible for the issue of an import certificate.

(3) Applications for the issue of an import certificate shall be made, provided that they are not to be transmitted in electronic form in accordance with a Regulation in accordance with Section 81a of the Medicinal Products Act, using the relevant forms provided by the The Federal Office for Health Security is to be published on its website.

(4) The import certificate shall be issued only if there are no objections to the production, storage, transport, indications, composition and therapeutic uses from a health point of view. The import certificate shall be temporary for a period of five years.

(5) The Federal Office for Safety in the Health Care has to prohibit it from being informed of the conditions for importation in accordance with paragraph 4.

(6) An import certificate as referred to in paragraph 1 shall not be required for the importation of natural medicinal products products for the person's own use.

6.

Powers of control and criminal provisions

Powers of the customs authorities

§ 19. (1) The import certificate in accordance with § 3, proof of the notification made pursuant to § 7 (1), § 8 (1), § 9 (1) or § 14 (1), the certificate of transport capability in accordance with § 12 (1) and the import certificate pursuant to § 18 (1) are required Documents relating to the customs declaration within the meaning of Article 62 of Regulation (EEC) No 2913/92 establishing the Community Customs Code (Customs Code), OJ L 327, 31.12.1992, p. No. OJ L 302, 19.10.1992, p. 1. In addition, these documents shall be required by the customs authorities and their institutions, within the limits of the powers granted to them pursuant to Article 29 of the Customs R-DG and this Federal Act, upon request.

(2) In order to ensure the failure or for the purposes of the protection of evidence, goods may also be provisionally seized by the institutions of the customs administration. These bodies shall display the seizure of the authority responsible for the prosecution and shall deliver the confiscated goods to the latter.

Powers of the institutions of the Federal Office for Health Security

§ 20. (1) The institutions of the Federal Office for Health and Safety in the healthcare sector or experts appointed by the Federal Office shall be empowered to enter and inspect land and buildings, to open and control containers and means of transport, as well as to rehearsals. in the quantity required for an investigation, to the extent necessary for the monitoring of compliance with the provisions of this Federal Law.

(2) The sample taken is, in so far as it is naturally possible, to be divided into two equal parts, which are to be officially closed, and which is not their proper assessment. Part of the party shall be left behind for evidence. No compensation is due for the samples taken.

(3) Paragraph 1 shall also apply to goods subject to customs surveillance. They shall be replaced by appropriate official registration marks.

(4) The persons referred to in § 4 (1), § 9 (1), § 13 (1) and 14 (2) have the Federal Office for Health and Safety (Bundesamt für Sicherheit im healthcare) as well as the experts assigned to enter, open and visit the buildings, containers and means of transport. and to tolerate the controls. In addition, they shall provide all information necessary for the enforcement of the law, provide documents and provide an insight into the records of the inventory and the other records. Where necessary, assistance shall be provided by these in the course of the checks.

(5) In the case of the handling of the powers of paragraphs 1 to 3, the Federal Office for Health Security shall pay particular attention to the fact that, in the event of interference with the legal sphere of the persons concerned, the proportionality of the powers of the person concerned is respected. The Federal Office for Health and Safety (Bundesamt für Sicherheit im Healthcare) as well as expert experts have to take care that any disturbance or obstruction of the holding, which is not strictly necessary, is avoided.

Criminal provisions

§ 21. (1) Who

1.		Medicinal products contrary to § 3, without import certificate, or
2.		in the case of medicinal products, the subsequent notification of the introduction in accordance with § 6 shall be forgiven or medicinal products spends without notification in accordance with § § 7, 8 or 9, or
3.		blood products, contrary to § 12, without a certificate of transport capability, or
4.		in the case of blood products, the subsequent notification of the introduction in accordance with § 14 para. 7 or blood products without notification in violation of § 14 para. 1, or
5.		Products of natural healing resources contrary to § 18 without import certificate, or
6.		the recording obligations in accordance with § 10 (3) or § 11 (5) or the obligations pursuant to § 15 are contrary, or
7.		the persons referred to in § 20 shall be refused entry, inspection, inspection or inspection or inspection of the records to be carried out under this Federal Act, or shall not comply with the orders of such persons,
If the offence does not constitute the offence of a criminal offence within the jurisdiction of the courts, an administrative surrender and a fine of up to EUR 3 600, in the event of a repetition of a fine of up to EUR 7 260 punishing.

(2) The attempt is punishable.

(3) The goods belonging to the perpetrator or co-culprit, which constitute the subject of the offence, may be declared forfeit if the act has been committed intentionally. The decay of these goods can also be recognized independently if no specific person can be prosecuted or punished.

Avoidance of trade diversion

§ 22. Competent authority in accordance with Article 1 (2) lit. (c) Regulation (EC) No 953/2003 on the prevention of trade diversion of certain basic medicinal products into the European Union, OJ L 327, 31.12.2003, p. No. OJ L 135, 03.06.2003, p.5, the Federal Office for Safety in Health is the Federal Office for Health.

Regulation authorisations for crisis situations

§ 23. (1) In the event of a catastrophe, epidemic, pandemic, terrorist threat, war or other crisis situations, the Federal Minister of Health, if the necessary supply of the population is otherwise seriously and seriously affected, has would be seriously threatened by regulation to make exceptions to the provisions of Sections 3 to 10, 12 to 15 and 18 of this Federal Law, if and as long as this is necessary because of the special situation and the protection of life and of the Health of humans and animals is maintained.

(2) A Regulation referred to in paragraph 1 shall not apply for a maximum period of six months.

Section 7

Transitional and final provisions

§ 24. Insofar as this federal law refers to provisions of other federal laws, these provisions shall be applied in their respectively applicable version. Insofar as this federal law refers to provisions of legal acts of the European Union, these are in their at the time of the entry into force of the Federal Law BGBl. I n ° 79/2010.

§ 25. For all personal names used in this Federal Act, the chosen form is valid for both sexes.

§ 26. (1) With the entry into force of this Federal Act, the Drug Goods Import Act 2002, BGBl. I n ° 28/2002, except for § 2 (6), except for force.

(2) Section 6 (3) enters into force with the entry into force of a regulation pursuant to Section 81a of the Medicines Act. Section 2 (6) of the Proprietary Medicinal Products Import Act 2002 shall be repeal of the Act at that time.

(3) On the date of the entry into force of this Federal Act, pending proceedings for the granting of an import permit pursuant to § 2 para. 1 or 12 of the Medicinal Product Import Act 2002 or a traffic certificate according to § 7 para. 1 of the The 2002 Medicinal Products Act is to be implemented in accordance with the Proprietary Medicinal Products Import Act 2002.

(4) With the entry into force of this Federal Act, the Ordinance of 13 April 1972 on the authorization of provincial general men to issue certificates of safety in accordance with the Proprietary Medicinal Products Import Act, Federal Law Gazette (BGBl). No 120/1972, except for force.

(5) By § 17, § 59 (9) of the Medicines Act and Section 50 (4) of the Industrial Regulations 1994, BGBl. No. 194/1994, not affected.

§ 27. With the enforcement of this federal law, insofar as matters of the customs tariff or customs law are affected or organs of the customs administration are acting, the Federal Minister of Finance in the

Agreement with the Federal Minister for Health, with regard to § 19 of the Federal Minister of Finance and the Federal Minister of Health.

Fischer

Faymann