23 Unirii Boulevard, Bl. 13, Entrance 1, 6th floor, Apt. 16, District 4, 040103, Bucharest

Open a pharmaceutical company in Romania

I am interested in setting up a pharmaceutical company. Can you offer me information on the matter?

The pharmacy is established and operates within a company organized under the provisions of law no. 31/1991 concerning companies.

The company will have the following activites as objects of activity: the retail trade of pharmaceutical products, officinal preparation of medicines and other health products; sale of cosmetics, pharmaceutical products, paramedical devices and equipment and supplies for individual use, food supplements and special purpose herbs, harmless herbs and herbal products based on harmless plants, infant care products, personal hygiene items, equipment, materials or products to protect or improve health, products for protection against sexually transmitted diseases or contraception action, homeopathic products, products for aromatherapy and other products for use in some pathological conditions;

Pharmaceutical companies function by the instrumentality of pharmacies.

What is the organization form of a pharmacy?

Pharmacies are headed by a chief pharmacist. The person qualified to be a chief pharmacist is the pharmacist who owns certified membership of the College of Pharmacists in Romania, issued under the law.

The pharmacy specialist staff consists of:

a) chief pharmacist;

b) pharmacists;

c) pharmacy nurses.

I heard there are some authorizations I need to obtain on this matter. Can you tell me more about this?

A pharmacy is based on the operating permit issued by the Ministry of Health.

The pharmacy’s activity is conducted in accordance with the Rules of good pharmaceutical practice, developed by the Ministry of Health in collaboration with the College of Pharmacists of Romania and approved by the Minister of Health.

The operating permit confers the following rights:

a) the right to own, to prepare and issue, under the law, psychotropic drugs and substances used for medical purposes;

b) the right to own, to prepare and issue, under the law, narcotic substances and their precursors drugs used for medical purposes;

c) the right to sign contracts with health insurance companies for the provision of pharmaceutical services.

How can I obtain these authorizations and what documents do I need?

The operating authorization is granted on behalf of the legal person and the chief pharmacist, by the Ministry of Health.

To obtain the authorization, the applicant shall submit the following documents:

a) application form;

b) employment contract or proof of the profession, for a full working time duration of 8 hours, for the unit chief pharmacist and membership certificate of the College of Pharmacists in Romania, issued under the law, accompanied by current professional certificate issued by the College of Pharmacists of Romania, in the form of a certified copy of the original;

c) the descriptions of the responsibilities of pharmacists, endorsed by the College of Pharmacists of Romania;

d) a certified copy of the original act of incorporation of said society;

e) the certified copy of the certificate of registration of the company with the Trade Register;

f) the certificate issued by the Trade Register, evidencing registration as a work space for the pharmacy or, where applicable, the registered office for the activity for which the  authorization is requested;

g) an outline of the rooms, certified by the legal representative of the applicant, in accordance with the model established by the Minister of Health;

h) a document certifying the right to use the space intended for the pharmaceutical unit;

i) a list of the provision of furniture, utensils and equipment;

j) proof of compliance with the provisions regarding the number of pharmacies adapted to the number of inhabitants;

k) the proof of payment for authorizing the establishment, namely 3,000 lei for pharmacies in urban areas and 150 lei for pharmacies in rural areas.

The documentation is submitted to the Ministry of Health.

The operating permit is issued following a favorable inspection report prepared by the specialists of the Ministry of Health.

The inspection shall be performed within 60 days of the application date.

In case of an inspection report with recommendations, there shall be granted a period of 30 days to remedy the deficiencies.

The operating permit is issued within 30 days after the inspection, in the case of a favorable inspection report .

Are there any other special conditions?

Yes, as stated above, the establishment of pharmacies in urban areas is based on the number of inhabitants, as follows:

a) in Bucharest, a pharmacy to 3,000 inhabitants;

b) in the county capitals, a pharmacy to 3,500 inhabitants;

c) in other cities, a pharmacy to 4,000 inhabitants.

The pharmacy works only in the presence of at least one pharmacist, who exercises the profession personally and who can not be replaced by a person of another profession.

The name of the pharmacy will include the phrase "pharmacy".

The emblem of the pharmacy will carry the distinctive symbol of the cross with the sides intersecting at right angles, equal-sized, green on white.

The display of the company logo is exempt from tax.

How can Darie, Manea & associates help me in the process?

Our team is ready to help you in the process of staring a pharmaceutical company with a team specialized on the matter, willing to meet your expectations and make sure the company is everything you need it to be. If you need any more information on the subject, please do not hesitate to contact us.

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