Requirements for a drugstore personnel for obtaining the license

As one may know, from the 20th of December, 2016, new licensing regulations entered into force in Ukraine (approved by the resolution of Cabinet of Ministers no. 929 dated the 30th of November, 2016). They set a number of requirements for the business entities, which are engaged in the retail of medicines (activities of drugstores).

In this publication we’ll focus, in particular, on licensing requirements for personnel of different types of drugstores.

To carry out the retail sale of medicines, a drugstore establishment and all its structural units at the time of applying for a license to the licensing authority (currently the State Service) must confirm they are well staffed with the personnel who received a pharmaceutical education of the appropriate level.

The key positions in a drugstore that must be filled at the time of the licensing inspection are a drugstore director and the person responsible for the quality of medicines (designated person). The requirements for these positions are very similar; in practice, quite often one person holds both positions.

Requirements to a Drugstore Director 

The requirements for persons applying for the position of a director of a drugstore, as well as for the position of Deputy Director of a drugstore, are established by the Licensing  conditions No. 929. In particular, this person must meet the following qualification requirements:

• have a documentary evidence of a higher education degree no lower than the 2nd (that is, master's) level in the specialty "Pharmacy";
• have a certificate of a pharmacist specialist in the specialty "Organization and Pharmacy" or be certified in the relevant specialization with the assignment (or confirmation) of the appropriate category;
• have at least 2 years of work experience in the field.

It should be noted that for the requirements for the personnel of the drugstores located in villages, towns or urban-type settlements that they are more simplified compared to the drugstores located in cities. In particular, the position of a director of a drugstore located in a village, town or urban type and their deputy may be applied for by persons who have documentary evidence of their higher education of no less than the 1-st level (that is, a bachelor) in the specialty "Pharmacy".

One should be aware that the Licensing  Conditions No. 929 expressly prohibit filling the position of a Director of a drugstore шт conjunction with other office.

Requirements to a Designated Person 

In accordance with the paragraph 165 of the Licensing Conditions No. 929, each drugstore establishment that is (planning to carry out) carrying out the retail sale of medicines is also required to appoint a Designated Person who will be responsible for operating a quality assurance system for  all medicines in the process of their retail sale at this drugstore.

The following qualification requirements are established for a Designated Person:

• documentary evidence of their higher education degree no lower than the 2nd (that is, master’s) level in the specialty "Pharmacy";
•  a certificate of a specialist pharmacist issued by one of the institutions of postgraduate education or a certificate of assignment to a given person (of proficiency testing)  of the corresponding qualification category;
•  Work experience in the specialty "Pharmacy" for at least 2 years.

As for a Director of the drugstore located in a village, town or urban-type settlements, as well as the Designated Person or Deputy Director of such drugstore, qualification requirements are less stringent, namely:

• documented confirmation of the obtained higher education degree no lower than the 1st (that is, bachelor) level in the specialty "Pharmacy" is allowed.
• there are no requirements for the required work experience in this field.

Requirements to the other drugstore staff

One of the key requirements of the law (paragraph 181 of the aforementioned Licensing  Conditions No. 929) is that all persons directly involved in the retail sale of medicines must have:

• documentary evidence of the obtained higher education degree no lower than the 1st (that is, a bachelor) level in the specialty "Pharmacy";
•  specialists with higher education no lower than the 2nd (that is, master's) level - one of the following documents:

- either a certificate of a specialist pharmacist issued by one of the institutions of postgraduate education,

- or a certificate of assignment of the corresponding qualification category to a given person (of his proficiency testing). 

Thus, the dispensing of medicines in drugstores, subject to strict observance of all requirements of the current legislation, can be carried out only by such categories of workers as:

•  pharmacists
•  clinical pharmacists;
•  specialist pharmacists.

We draw your attention to the fact that people who have not worked for more than 5 years in the specialty indicated in their diploma (authorization document  or certificate) are allowed to work only after they have passed the appropriate professional retraining. In addition, the Ministry of Health has determined a separate procedure for admission of the persons who have undergone special training in foreign educational institutions to the conduct of professional activities, including in the pharmacy sector.

All employees of drugstores and their structural units must undergo a medical examination when getting hired and subsequent periodic medical examinations.

Also, for the drugstore workers whose activities are directly related to the retail sale of medicines, the employer must approve their job descriptions, which should contain information about the main functions and duties, professional knowledge, competence and other statutory requirements for employees.

Thus, the current legislation, namely Licensing Conditions No. 929, clearly defines the qualification and some other special requirements for the drugstore personnel, the observance of which is a prerequisite for successfully obtaining a license for the retail sale of medicines.