BGBl. II – Issued on 18 February 2020 – No 30 2 of

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FEDERAL LAW GAZETTE

Draft
OF THE REPUBLIC OF AUSTRIA

Ordinance of the Federal Minister for Labour, Social Affairs, Health and Consumer Protection on ensuring the supply of medicines
Year 2020 Issued on 18 February 2020 Part II

Pursuant to § 57a(2) of the Medicines Act [Arzneimittelgesetz], Federal Law Gazette No 185/1983, last amended by the Federal Act published in Federal Law Gazette I No 100/2018, the following is hereby enacted:
30th Ordinance: Ensuring the supply of medicines

Article 1. (1) The marketing authorisation holder shall notify the Federal Office of Public Health of any restriction of the domestic distribution of a prescription medicinal product. A restriction of distribution shall be defined as a situation of unavailability expected to last for more than two weeks, or a situation of insufficient availability expected to last for more than four weeks, of a prescription proprietary medicinal product necessary to cover the needs of domestic patients.
30th Ordinance of the Federal Minister for Labour, Social Affairs, Health and Consumer Protection on ensuring the supply of medicines

Pursuant to § 57a(2) of the Medicines Act [Arzneimittelgesetz], Federal Law Gazette No 185/1983, last amended by the Federal Act published in Federal Law Gazette I No 104/2019 and the Federal Ministries Act Amendment 2020, Federal Law Gazette I No 8/2020, the following is hereby enacted:

§ 1. (1) The marketing authorisation holder shall notify the Federal Office For Safety in Health Care of any restriction of the domestic distribution of a prescription proprietary medicinal product. A restriction of distribution shall be defined as a situation of unavailability expected to last for more than two weeks, or a situation of insufficient availability expected to last for more than four weeks, of a prescription proprietary medicinal product necessary to cover the needs of domestic patients.

(2) In accordance with the requirements of the Ordinance of the Federal Office for Safety in Health Care, the notification pursuant to Paragraph 1 shall be made through the electronic submissions system for applications and notifications (Electronic Submission Ordinance [Elektronische Einreichverordnung - EEVO] 2011).

(3) The Federal Office for Safety in Health Care shall publish the medicinal products notified in accordance with Paragraph 1 in a publicly accessible list on its website.
(3) After verifying the notification referred to in Paragraph 1, the Federal Office for Safety in Health Care shall publish the proprietary medicinal product in a publicly accessible list on its website no earlier than on the day that the restriction of distribution actually occurs.

Article 2. Once the restriction of the distribution of a prescription proprietary medicinal product is no longer present, the marketing authorisation holder shall notify the Federal Office for Safety in Health Care. § 1(2) shall apply accordingly. After an appropriate review, the Federal Office for Safety in Health Care shall immediately delete the relevant proprietary medicinal product from the list as per § 1(3).
(4) The verification of the marketing authorisation holder’s notification of the restriction of distribution of the proprietary medicinal product concerned shall relate in particular to the number of patients concerned, market coverage, average sales figures, calculated needs and stocks, and available potential alternative medicinal products.

Article 3. (1) If the Federal Office for Safety in Health Care becomes aware that the marketing authorisation holder (partially) fails to fulfil his obligation under § 1(1), the Federal Office for Safety in Health Care shall, after verification, include the relevant proprietary medicinal product in the publicly accessible list pursuant to § 1(3) if appropriate.
(5) The Federal Office for Safety in Health Care shall regularly check that the list referred to in Paragraph 3 is up to date.

(2) If there are restrictions on the domestic supply of prescription proprietary medicinal products which are provided adequately and continuously by the marketing authorisation holder to meet the needs of domestic patients, the Federal Office for Safety in Health Care shall also include such prescription proprietary medicinal products in the publicly accessible list pursuant to § 1(3), in consultation with the marketing authorisation holder.
§ 2. (1) In the event that the restriction of domestic distribution of a prescription proprietary medicinal product is no longer present, the marketing authorisation holder shall notify the Federal Office for Safety in Health Care. § 1(2) shall apply accordingly.

(3) If the distribution restriction as referred to in Paragraph 1 or the supply restriction as referred to in Paragraph 2 is no longer present, § 2 shall be applied analogolously.
(2) The Federal Office for Safety in Health Care shall verify this and, in the event that the restriction of distribution is no longer present, immediately delete the relevant proprietary medicinal product from the list as per § 1(3).

Article 4. To ensure the protection of public health, the export of prescription proprietary medicinal products included in the list published by the Federal Office for Safety in Health Care pursuant to § 1(3) to another Member State of the European Economic Area shall be prohibited.
(3) If the marketing authorisation holder fails to fulfil their obligation under Paragraph 1, the Federal Office for Safety in Health Care may, after verification, perform an ex officio deletion.

Article 5. This Ordinance was subject to a notification procedure within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
§ 3. (1) If the Federal Office for Safety in Health Care becomes aware that the marketing authorisation holder fails to fulfil their obligation under § 1(1) in full or in part, the Federal Office for Safety in Health Care shall, after verifying that a restriction of distribution exists, include the relevant proprietary medicinal product in the publicly accessible list pursuant to § 1(3).

(3) If a distribution restriction as referred to in Paragraph 1 is no longer present, § 2 shall apply, mutatis mutandis.

§ 4. (1) If the Federal Office for Safety in Health Care becomes aware that a prescription proprietary medicinal product is not covering the needs of domestic patients, although no restriction of distribution has been notified by the marketing authorisation holder, the Federal Office for Safety in Health Care shall, after verification, include the proprietary medicinal product in the publicly accessible list as per § 1(3).

(2) In the event that any other restriction is no longer present pursuant to Paragraph 1, the Federal Office for Safety in Health Care shall, after verification, perform an ex officio deletion of the relevant proprietary medicinal product from the list as per § 1(3).

§ 5. (1) To ensure the protection of public health, the export of prescription proprietary medicinal products included in the list published by the Federal Office for Safety in Health Care pursuant to § 1(3) to another Member State of the European Economic Area shall be prohibited.

(2) At the request of the marketing authorisation holder, the Federal Office for Safety in Health shall issue a decision on the export ban referred to in Paragraph 1.

§ 6. This Ordinance was subject to a notification procedure within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).

§ 7. This Ordinance shall enter into force on 1 April 2020.

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