This newsletter addresses the main legal and case law changes for the month of September 2016.

BANKING & FINANCE

Credit agreements

The emergency government ordinance no. 52 of September 14, 2016 on credit agreements for consumers regarding immovable assets and amending and supplementing the Emergency government ordinance no. 50/2010 on consumer credit agreements has been published in the Official Gazette, Part I, no. 727 of September 20, 2016. The ordinance sets out the rights and obligations of the parties in respect of credit agreements for consumers on the sale or purchase of immovable assets, credit agreements secured by a mortgage on immovable assets and credit agreements having as object a right related to an immovable asset. The consumers have the right to convert, at any time during the contractual relationship, a credit agreement in foreign currency in an alternative currency. The ordinance prohibits creditors to raise their fees, to introduce new commissions, tariffs and expenses. In relation with contractual clauses, it is forbidden the unilateral amendment made by the creditor without concluding an addendum accepted by the consumer. The annual interest rate shall be calculated in accordance with the mathematical formula set out in Annex no. 1.

FISCALITY

Customs duties

Order no. 2,554 of September 6, 2016 on the Procedure for the authorisation of customs duty-free imports of goods by organisations or institutions under articles 43-53, 57-59, 61-80 and 82 of the Council Regulation 1186/2009 setting up a Community system of reliefs from customs duties has been published in the Official Gazette, Part I, no. 712 of September 14, 2016. For the purpose of the authorisation of customs duty-free imports of goods, the organisations or institutions will submit the applications for authorization to the Regional Directorates General of Public Finance in whose jurisdiction they are established, as the model set out in Annex no. 1. Annex no. 2 set out the decision model for the authorisation of customs duty-free imports of goods. Decisions shall be issued for the authorisation of customs duty-free imports of goods by organisations or institutions for educational, scientific and cultural materials, goods intended for people with disabilities, reference substances for medicine quality control, etc.

HEALTH

Medical devices

Order no. 1,008 of September 6, 2016 approving the Methodological Norms for enforcing Title XX of Law no. 95/2006 on healthcare reform, relating to the advising of activities in the field of medical devices has been published in the Official Gazette, Part I, no. 736 of September 22, 2016. The marketing activities and services in the field of medical devices subject to control are the following: import, storage, distribution, repair, maintenance and installation of medical devices, medical optics and prosthetics. The operating permit and its annexes are issued by the National Agency of Medicines and Medical Devices. The operating permits issued in accordance with these norms shall be valid for an indefinite period if the issuance conditions remain unchanged. Annex no. 1 set out the application/notification for the issuance of an operating permit. Order no. 798 of September 8, 2016 on the registration of the medical devices in the national database has been published in the Official Gazette, Part I, no. 705 of September 12, 2016. The Order establishes the way of registration of medical devices which are placed on the market by authorised natural persons or legal persons established in Romania, and also of the person responsible for placing on the market the medical devices. The medical device registration certificate shall be issued within 60 days from the receiving of the notification form completed with all data and accompanied by the appropriate documentation. Imports of medical devices shall be based on the manufacturer’s declaration of compliance or on the custom declaration.