Pharmaceutical Legislation Update – New Joint Ministerial Decision Commentary

Joint Ministerial Decision of the Ministers of Economy, Development, Tourism and Health no. 36277/2016 (Government Gazette, B series, issue no. 1445/23-05-2016) attempts a concentrated legislative regulation of the basic procedures and conditions regarding the setting up and operation of pharmacies.

The main points are the following:

–  A pharmacist applying for a second (or third, etc.) license to set up a pharmacy, is under an obligation to state the full personal details of the pharmacist who is to be responsible for the pharmacy’s operation, already at the stage of filing the application for being granted a license to set up a pharmacy and not at a later stage.

The pharmacist who is to be responsible has to register with the relevant pharmacists association.

– In respect of the year 2020, the maximum number of licenses allowed to be granted to the same natural person for setting up pharmacies, can rise up to ten. Accordingly, until 2020, any natural person can participate in up to ten, at maximum, pharmacy operating partnerships or capital companies.

– No pharmacy setting up license can be granted to a legal entity.

–  A pharmacy, for the setting up of which a license is granted to a non-pharmacist private individual, necessarily operates as a Limited Liability Company (LLC; EPE, in Greek), which must have been established before the pharmacy operating license is granted. The pharmacist appointed as responsible (per the above) is required to participate in the LLC’s shareholding composition, by holding at least 20% of the company’s share capital.

According to the new J.M.D., it is mandatory for this condition to be met throughout the period of the pharmacy’s operation by the LLC and regardless of any possible transfer of the LLC’s company percentages. Therefore, a license granted to a non-pharmacist is “identified” with the person of the responsible pharmacist.

Population criteria as regards the number of licenses remain in force.

– Pharmacies having a pharmacist as licensee, can operate either as private enterprises or as commercial companies of any form, other than that of a société anonyme. Such companies must have the operation of a pharmacy as their exclusive objective.

– For the first time, certain categories of persons are prohibited from participating as partners/shareholders (not as licensees) in companies operating pharmacies; such categories are:

  • doctors and dentists;
  • legal entities founded by doctors or dentists;
  • natural or legal persons having the operation of all types of diagnostic centers or the production, import, agency or wholesaling and trading in pharmaceuticals as their main or ancillary activity;
  • natural or legal persons participating in any capacity (as legal representatives, or shareholders, or partners, or shareholders of a third legal entity) in the aforementioned companies, or in companies associated therewith (under specific conditions).
  • Participation of a spouse, or of an, up to the second degree, relative by blood or marriage of the above natural persons, is also prohibited.

– In that sense, it is made clear that a legal entity is also entitled to participate in a pharmacy operating company.

– The age limit of licensee pharmacists is abolished.

– It is mandatory for the pharmacy operating companies established, as well as for private enterprises, to have their seat at the pharmacy and to have a specific term and activity objective. Nonetheless, for the first time, they are allowed to set up branches, provided a separate license has been granted for each branch set up.

– The conditions for acquiring a license to set up a pharmacy are stated afresh; these are:

  • The applicant pharmacist or the responsible pharmacist appointed by the applicant private party must hold a license to practice the pharmacist’s profession in Greece or in another member-state of the E.U.
  • Greek or another E.U. member state nationality or citizenship;
  • Clean criminal record;
  • Not owing debts out of taxes, fines or on any other ground to the Greek State;
  • Not having been penalized by a definitive revocation of the license for setting up a pharmacy or a pharmaceutical warehouse.

– The procedure for filing applications and for granting licenses with regard to spare posts in each Regional unit (a procedure conducted twice a year, each February and July), is redefined.

– General criteria are: seniority in obtaining the license to practice, seniority of graduating from the Faculty of Pharmacy, the university degree’s grade, coming from a family with many children, etc.