The Romanian Competition Council issued new guidelines for the setting of fines, which were published on November 3rd 2016. The guidelines also provide for the applicable procedure should a company acknowledge the infringement (similar with the settlement procedure at the level of the European Commission).

UPDATE (October 31) – The Decision has been published under no. 800/2016 in the Official Gazette no. 869/2016.

A draft Government Decision on the approval of the Methodology of the calculation system and approval procedure of the maximum prices of medicinal products for human use authorized for marketing in Romania was published on 12 October 2016 on the website of the Ministry of Health. The draft Government Decision is available here.

A draft Government Decision on ensuring the transparency of the healthcare system was published on 7th of October 2016, on the website of the Ministry of Health. The Romanian version of the draft Government Decision is available here.

The unblock of the online gambling industry in Romania, with the enactment of several legislative pieces which set the premises for effectively allowing online gambling to be legally offered in the jurisdiction, took operators and service providers interested in the market as well as their lawyers on a high speed roller coaster ride of relentless loops and twists which nonetheless reached the “full license” final destination safely.

The Government Emergency Ordinance no. 59/2016 on the amendment of Article 890 of Law no. 95/2006 was published in the Romanian Official Gazette no. 768 of September 30, 2016 (attached hereto).

According to a press release, during the Government’s session from September 28th, 2016, an Emergency Government Ordinance was adopted for the modification of Article 890 of Law 95/2006 on the reform of the healthcare system (Law 95/2006), according to which the new methodology on the calculation system and approval procedure of the maximum prices of medicinal products for human use authorized for being placed on the Romanian market will be approved by Government Decision, pursuant to the proposal of the Ministry of Health.

Recent initiatives of the Romanian National Agency for Fiscal Administration (the “NAFA”) – including on site controls – showcase the Agency’s interest in verifying the VAT and PE structures set-up and deployed for business purposes by the international companies active in the pharmaceuticals sector in Romania.

Published in “Casino Inside”, issue 65

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