Life Sciences: Product Regulation And Liability In Romania

TRENDS AND DEVELOPMENTS

Legal developments

Are there any notable trends or recent legal developments in your jurisdiction's pharmaceutical industry?

One recent legal development in the pharmaceutical field is the change of methodology for establishing prices for medicinal products which are totally or partially paid for by the social security system. However, already representatives from associations of medicine producers are pushing for this methodology to be revised, claiming that its overall impact on the market is negative and that lowering the prices of medicines to unsustainable levels will end up reducing the variety of medicines available.

Another foreseeable development is the adoption of a bill amending the Pharmacy Law (266/2008), introducing regulations on the online sales of medicinal products (266/2008). This bill would make possible the online sale of medicinal products in Romania, while also aligning the Romanian legislative framework with European regulations in this area.

LEGAL FRAMEWORK

Legislation

What is the primary legislation governing medicinal products in your jurisdiction?

The primary legislation governing medicinal products in Romania consists of the Healthcare Reform Law (95/2006), the Pharmacy Law (266/2008), the Illicit Drug Trafficking Law (143/2000), the Dangerous Chemical Substances Law (360/2003) and the Medicinal and Aromatic Plants Law (491/2003).

Additionally, numerous regulations set out rules for specific areas, including:

Ministry of Health Order 1295/2015 on authorisation to manufacture medicines; Ministry of Health Order 131/2016 on authorisation to distribute human-use medicines; Ministry of Health Order 1962/2008 on parallel imports; Government Decision 800/2016 on the methodology for calculating and approving maximum prices for human-use medicines (except for over-the-counter medicines) authorised for sale in Romania; Emergency Ordinance 121/2006 on drug precursors; Government Decision 734/2010 on the organisation and functioning of the National Agency for Medicines and Medical Devices; and Ministry of Health Order 194/2015 on advertising medicinal products. In addition, since Romania is part of the European Union, the Regulation on the Authorisation and Supervision of Human-use and Veterinary Medicines (726/2004/EC), the Regulation for the Amendment of Directive 2001/83/EC on Good Manufacturing Practices (1252/2014) and the Regulation on Clinical Studies (536/2014/EC) all apply directly.

Are any legislative changes proposed or expected in the near future?

A draft bill on the amendment of the Pharmacy Law was adopted by the first chamber of Parliament in September 2016, introducing regulations for the online sale of medicinal products. However, the regulation will not come into force until it has been ratified by the second chamber.

Regulation

Which bodies regulate medicinal products in your jurisdiction and what is the scope of their powers?

Medicinal products are regulated in Romania by the Ministry of Health, through the National Agency for Medicines and Medical Devices. While the ministry is responsible for setting national priorities in public healthcare and coordinating the allocation of funds, the agency is in charge of regulating medicines and market supervision. Its powers range from the issuance of marketing authorisations, the supervision of clinical studies and the assessment and approval of laboratories to market supervision. However, certain authorisations (eg, for the manufacture of psychoactive substances) also require approval from the ministry.

Are any other legal regimes applicable to the trade of medicinal products (eg, competition, international trade, data protection, consumer protection)?

The trade of medicinal products falls within the scope of laws regulating different fields, such as competition, international trade (including parallel imports), data protection, consumer protection, taxation and intellectual property.

Are any medicinal products exempt from regulation (eg, complementary and alternative medicines)?

No medicinal products are exempt from regulation. Complementary and alternative medicines are regulated by Law 118/2007.

SUPPLY

Manufacture

What is the authorisation procedure for the manufacture of medicinal products in your jurisdiction?

In order to manufacture medicinal products, producers must file a request for manufacturing authorisation with the National Agency for Medicines and Medical Devices. This must be accompanied by a number of documents (eg, the applicant's articles of incorporation and proof of registration with the Trade Registry), as well as by the standard technical file for the medicine, as detailed in Part III of the European Commission's Good Manufacturing Practices Guidelines. On the filing date the applicant must also request that the agency inspect the premises where production will take place. Following this inspection the agency may ask the applicant to submit additional documents or to take compliance measures. It will then either reject or approve the application. If the latter, the manufacturing permit will be issued within 90 days of the completed application filing date. The agency will issue a good manufacturing practices certificate within 90 days of a satisfactory inspection.

What is the fee for obtaining authorisation?

The inspection necessary for a manufacturing authorisation to be granted is subject to a fee of between €1,561 and €1,742, depending on the type of products to be manufactured (ie, sterile or non-sterile products). Additional fees may be charged according to the number of production streams inspected by the National Agency for Medicines and Medical Devices during the authorisation process or where a second inspection turns out to be necessary. The issuance of the good manufacturing practices certificate is subject to a fee of between €1,753 and €2,035, according to the type of products being manufactured.

What is the validity period for authorisation?

The law does not provide for a validity period for manufacturing authorisations. However, holders must renew or amend the authorisation whenever an element on which it was issued is changed.

How robust are the standard good manufacturing practices followed in your jurisdiction?

The Standard Good Manufacturing Practices Guide followed in Romania is detailed and fit for purpose, being based on and closely following the wording of the European Commission's Good Manufacturing Practices Guidelines and of the EU Directive on Good Manufacturing Practice for Medicinal Products for Human Use (2003/94/EC).

What are the consequences of failure to obtain manufacturing authorisation and/or follow good manufacturing practices?

Manufacturing medicines without an authorisation from the National Agency for Medicines and Medical Devices is a misdemeanor, as established by Article 875(1)a of the Healthcare Reform Law (95/2006), punishable by the closure of the production unit and fines of between €2,200 and €6,600. Article 875(1)d establishes that failing to observe good manufacturing practices is subject to a fine of between €2,200 and €6,600.

Distribution

How are the distribution and storage of medicinal products regulated?

The distribution and storage of medicinal products is governed by the Healthcare Reform Law (95/2006) and by Ministry of Health Order 131/2016 on authorisation for en-gross distribution units for human-use medicines.

According to these, the holder of a manufacturing authorisation is entitled to distribute the authorised medicinal products. Aside from this implicit authorisation, any person applying to obtain a distribution authorisation must be able to prove to the National Agency for Medicines and Medical Devices that it has appropriate storage space, installations and equipment, and that it benefits from the services of qualified personnel. In addition, the applicant must be able to prove that both its suppliers and its clients are authorised to manufacture, distribute or place medicines on the market.

Import and export

How are the import and export of medicinal products regulated?

According to Law 26/2006 the import of medicinal products or active substances depends on first obtaining a manufacturing authorisation. This is also compulsory for medicinal products manufactured exclusively for export.

Are parallel imports permitted in your jurisdiction?

Yes. The procedure for issuing an authorisation for parallel imports is regulated by Ministry of Health Order 1962/2008.

The authorisation is issued by the National Agency for Medicines and Medical Devices, subject to a fee of approximately €150. It will be issued only if the following conditions are met:

The marketing authorisation is intended for domestic sales. The medicine is imported from a country within the European Union or the European Economic Area. The imported medicine is authorised for marketing within the European Union or the European Economic Area. The imported medicine is sufficiently similar to prior approved domestic medicines, even if its excipients differ. Sale and purchase

What rules govern the dispensing, sale and purchase of medicinal products?

The Healthcare Reform Law (95/2006) and the Pharmacy Law (266/2008) cover the dispensation, sale and purchase of medicinal products in Romania.

Such sales are possible only after a marketing authorisation has been obtained from...