Regional Factbooks

Standards and Regulations: Drug manufacturers must apply for registration of their products with the Romanian Institute for Drug Control (ICSMCF). If the application is approved by a drug commission named by the authorities, the registration procedure takes between 6 and 12 months and the drugs are checked for conformity with analysis certificates submitted within the registration dossiers. If drugs are to be introduced into the country by the World Bank, the registration time is drastically reduced. All drugs possessing certificates of registration from EMEA (European Medicine Evaluation Agency) are registered within 3 to 4 months. Registered drugs must meet the standards of good manufacturing practice (GMP certificate for the manufacturer) and must have a free sales certificate released for the country where they are manufactured. The fee for registration in ICSMCF is about $500. Legislative requirements for registration are identical with the E.U. guidelines. Application for registration must be made by a Romanian sponsor, a Romanian agent, distributor or company based in Romania. New drugs must be registered if they are new to the Romanian market and are innovative and of good quality.

Labels and leaflets must be translated into Romanian. Customs duties, between 8-20%, are applicable. The VAT value amounts to 18% for big companies with turnovers of more than Romanian leu 40 million. A 38% tax on profit is applicable.

Impediments: Fluctuation of the exchange rate over the past year has been significant and companies should take this into consideration in making deals.

Recommendations: Stable relation between manufacturer and importer; preferential condition to overcome periodical problems (consignment, credit in the initial stage, etc.).

Distribution/Business Practices

There are approximately 300 manufacturers, importers and distributors of drugs on the Romanian market. Of the more than 200 distributors, the first ten listed below account for 50% of the market, having a large offer of products/companies. In this field it is quite difficult to build big sales quickly; the newcomer has two options: to contact one of the first distributors to make significant agreements, or to contact one of the smaller distributors with growth potential and to invest in it in order to obtain a solid partnership.

Sales are mainly by state tender or direct purchase. The distributing company must have good quality contacts in Romania, in order to have access to appropriate authorities with decision-making
power in purchasing. Otherwise, the chances are reduced, even with good price and quality. Suppliers contact hospitals and pharmacies directly. The OTC market is growing due to increased marketing and advertising of products directly to the consumer. There is some distrust of advertising by medical or pharmacy staff.

Financing:

The most common financing method used is payment by bank transfer with terms of 60 days after the supplier invoices the purchaser.

Key Contacts:

Ministry of Health Pharmaceutical Division Str. Ministerului 1-3 Bucharest, Romania Tel. (40-1) 613-61-47 Fax (40-1) 613-66-90 Contact: Dr. Dumitru Lupuleasa

State Institute of Drug Control "P.Ionescu-Stoian" Str. Aviator. Sanatescu 48 Bucharest, Romania Tel. (40-1) 666-60-70 Fax (40-1) 312-97-83 Contact: Dr. Dumitru Dobrescu

Romanian Assn. of International Drug Producers Hotel Modern Blvd. Carol I 44-46 et.12 Tel. (40-1) 250-56-90 Fax (40-1) 250 64- 99 Contact: Dr. Nicolae Voiculescu

Manufacturers

Antibiotice SA Str. Valea Lupului 1 Iasi, Romania Tel. (40-32) 142770 Fax (40-32) 211020 Contact: Mr.V.Munteanu

Armedica SA Str. Cuza-Voda 99 Tg. Mures, Romania Tel. (40-65) 137820 Fax (40-65) 164067 Contact: Mr.Ion Boitan

Biofarm SA Str. Logofat Tautu 99 Bucharest, Romania Tel. (40-1) 330-48-32 Fax (40-1) 330-56-32 Contact: Mr.Iacob Barbos

Europharm SA Str. Poienelor 5 Brasov, Romania Tel. (40-68) 310006 Fax (40-68) 314026 Contact: Mr. Miron Mihai

Sicomed SA Str. Th.Pallady 52 Tel. (40-1) 312-19-23 Fax (40-1) 312-90-13 Bucharest, Romania Contact: Mr. V. Teodorescu

Sindan SA Blvd. 1 Mai 11 Bucharest, Romania Tel. (40-1) 3120191 Fax (40-1) 3120249 Contact: Mr. Dan Stoicescu

Terapia SA Str. Fabricii 124 Bucharest, Romania Tel. (40- 64) 415099 Fax (40-64) 415105 Contact: Mr. Iuliu Osianu

Importers - Distributors

A&A Trading SRL Str. Viitorului 17-19 Bucharest, Romania Tel. (40-1) 210-23-61 Fax (40-1) 210-62-34 Contact: Mr. Adrian Zamfirescu

Alsifcom Intermed Str. Ceahlau 5 Cluj, Romania Tel. (40-64) 196365 Fax (40-64) 198553

Dita Import Export Str. Octavian 42 Bucharest, Romania Tel. (40-1) 323-78-13 Fax (40-1) 323-45-29 Contact: Mr. Adrian Tarus

Farmexim SA Blvd. Republicii 32 Bucharest, Romania Tel. (40-1) 312-39-62 Fax (40-1) 312-06-97

Heliofarm SA Str. Aurel Vlaicu 62 Constanta, Romania Tel. (40-41) 684554 Fax (40-41) 674586 Contact: Mr. Mihai Cazacincu

Imedica SA Str. V. Stroescu 5 Bucharest, Romania Tel. (40-1) 250-71-79 Fax (40-1) 250-21-99 Contact: Mr. Prejmereanu Ioan

Montero SRL I.C.Bratianu 34 Bucharest, Romania Tel. (40-1) 410-41-63 Fax (40-1) 312-19-93 Contact: Mr. Radu Tudorache

Pharma Salto-Med Str. Pasteur 24 Cluj, Romania Tel. (40-64) 438710 Fax (40-64) 132966

Relad International Str. Grivitei 7 Bucharest, Romania Tel. (40-1) 312-96-04 Fax (40-1) 312-96-68 Contact: Mr. Tiberiu Zigu-Manu

Romferchim SA Spl. Independentei 202A Bucharest, Romania Tel. (40-1) 638-37-90 Fax (40-1) 211-47-23

Tamisa Trading Hotel Bucuresti Str. Luterana 2-4 Bucharest, Romania Tel. (40-1) 312-58-12 Fax (40-1) 312-58-15 Contact: Mr. Anthony Gibbs

Valmedica SA Str. Dristor 96 Bucharest, Romania Tel. (40-1) 321-20-91 Fax (40-1) 321-20-94 Contact: Mr. Meir Greenberg

Publications:

There is a large number of medical publications. A local consultant has to be contacted to advise on the best publication to be used at one given moment.

Organizations/Associations/Independent Agencies:

Association of Romanian Drug Importers (ARPIM) Tel.: (40-1) 250.56.89 Fax: (40-1) 250.64.99 Contact: Diana Dafincescu

Consultants:

Exmarket Global Pharma Ltd. Tel/Fax (40-1) 311-30-72 Contact: Petru Craciun

V.Tarus Romanian Agencies Srl Bd. Unirii 23, bl.13, sc. 1 et.2 70401 Bucharest, Romania Tel.: (40-1) 337-11-41; 337-11-97; 337-23-60 Fax: (40-1) 337-26-11 Contact: Diana Szedlacsek, Consulting and Regulatory Affairs Dpt. Fax: (40-1) 211-29-52

Austria office: Valentin Aru, General Manager, Stuwerstrasse 32/12 A-1020 Wien Tel.: (0043)-1-7286811 Fax: (0043)-1-728681150

Romexpo Exhibition Centre: Bdvd. Marastii 65-67 P.O.Box 32-3 Tel.: (0040)-1-223.1160/223.1161 Fax: (0040)-1-312.8400/222.6169 Contact: Marin Paris, General Manager Demographics & Economic Situation

Demographics & Economic Situation

Source: Factbook.net