A DRAFT REGULATION OF THE MINISTER OF HEALTH AMENDING THE REGULATION ON THE LIST OF ACTIVE SUBSTANCES CONTAINED IN MEDICINES, THE LIST OF FOODSTUFFS FOR PARTICULAR NUTRITIONAL USES, THE LIST OF MEDICAL DEVICES AND THE LIST OF DIAGNOSTIC TESTS HAS BEEN MADE AVAILABLE

On 21 March 2015, a draft regulation of the Minister of Health amending the Regulation of 20 October 2015 on the list of active substances contained in medicines, the list of foodstuffs for particular nutritional uses, the list of medical devices and the list of diagnostic tests (hereinafter referred to as the "draft regulation") was made available on the website of the Government Legislative Centre.

The aim of this project is to improve the incorrectly defined route of administration of a medicine called Oxycort (Oxytetracyclinum + Hydrocortisoni Acetas) in the amended regulation. In the amended Regulation, the route of administration of this medicine is defined as oral and should be administered to the skin.

In addition, in table 3 of Annex 3 of the amended Regulation, designated as a list of medical devices for which nurses and midwives are entitled to issue prescriptions and recommendations, item 28 is added: insulin syringes and needles. The extension of the list is intended to align the provisions of the draft regulation with the provision of § 9 para. 1 point 1(b) of the Regulation of the Minister of Health of 28 October 2015 on prescriptions issued by nurses and midwives.

As indicated in the explanatory memorandum, the scope of the proposed amendments is small but significant for preserving the health of citizens.

The Regulation shall enter into force on the day following that of publication.

The draft regulation is available at: https://legislacja.rcl.gov.pl/projekt/12296500/katalog/12421508#12421508


Author: Wiktoria Jaromska – KONDRAT Law Firm and Partners
biuro@kondrat.pl

photo source: www.pixabay.com