Procedures for the Issuing, Re-registering and Withdrawing of Professional Qualification Certificates of Pharmacists

Issued pursuant to
Section 5, Clause 1 and Section 57 of the Pharmaceutical Law

I. General Provisions

1. This Regulation prescribes the procedures for the issuing, re-registering and withdrawing of professional qualification certificates of pharmacists (hereinafter - the certification).

2. A professional qualification certificate of a pharmacist (hereinafter - the certificate) is a document issued in accordance with the procedures specified in this Regulation, which attests to the conformity of the pharmacist with the requirements specified in the Pharmaceutical Law and gives the right to manage a pharmacy.

3. A certificate shall be issued for five years.

[21 January 2014]

II. General Requirements of Certification

4. Certification and re-certification shall be performed by the Professional Qualification Certification Commission of Pharmacists of the certification authority (hereinafter - the Certification Commission), which, in accordance with the requirements specified in the standard LVS EN ISO/IEC 17024:2005 "Conformity assessment. General requirements for bodies operating certification of persons" has been accredited in the State limited liability company "Standardisation, Accreditation and Metrology Centre" in the National Accreditation Bureau of Latvia. The composition of the Certification Commission shall include persons with a higher pharmaceutical education who are not in the conflict of interests and cannot influence the impartiality and independence of the certification process due to commercial or other considerations.

5. A certification authority shall:

5.1. perform certification in accordance with the requirements specified in the standard and criteria for certification which includes the knowledge of pharmaceutical, public health, management, and personal competences issues;

5.2. inform a pharmacist to be certified regarding the certification requirements, evaluation system and the composition of the certification examination commission;

5.3. organise the making and issuing of certificates;

5.4. organise the making and issuing of certificate-tags of certified pharmacists;

5.5. create and update the register of certified pharmacists and issue information regarding certified pharmacists at the Health Inspectorate and the State Agency of Medicines;

5.6. ensure the recording of minutes of meetings of the Certification Commission and the organisation of record-keeping and storage of documents related to the certification;

5.7. issue or send a justified decision regarding the refusal to grant the certificate to the relevant person in the form of a registered postal item, if the requirements referred to in this Regulation have not been observed, or to re-issue the certificate, as well as regarding the withdrawal of the certificate in the case referred to in Paragraph 22 of this Regulation within 10 days after taking of the relevant decision.

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6. A pharmacist who conforms to the requirements specified in the Pharmaceutical Law has the right to apply for the receipt of the certificate.

III. Certification and Re-certification

7. In order to acquire the certificate, a pharmacist shall submit a submission to the certification authority (Annex 1). The following documents shall be appended to the application:

7.1. a copy of the document attesting to the pharmaceutical higher education;

7.2. a copy of the document attesting to the change of surname (given name), if the surname (given name) has been changed;

7.3. a statement issued by an employer attesting to professional activity in the specialty within the last three years;

7.4. a copy of the document attesting to the knowledge of the official language of the pharmacist at the highest level, in accordance with the requirements of the Official Language Law, if the pharmacist has acquired a general secondary or higher education in a language other than Latvian;

7.5. an opinion issued by the family doctor or occupational disease physician regarding the conformity of his or her state of health with the work to be performed;

7.6. a copy of the passport;

7.7. two photographs (3.5 x 4.5 cm).

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8. The Certification Commission shall review the submission of the applicant, evaluate the documents appended thereto and inform the pharmacist to be certified regarding the time and place of certification examination within two weeks after receipt of the documents referred to in Paragraph 7 of this Regulation.

9. The Certification Commission shall take a decision regarding granting of the certificate within two weeks after receipt of the results of the test of professional knowledge of the pharmacist to be certified.

9.¹ If the pharmacist to be certified does not pass the certification examination:

9.¹ 1. with the first attempt, he or she shall have the right to take a certification examination one more time without a time limit;

9.¹ 2. repeatedly and less than a year has passed between this certification examination and the previous failed certification examination, the pharmacist is allowed to take the next certification examination not sooner than a year after the Certification Commission has taken a decision to refuse to grant the certificate due to failed certification examination.

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10. A pharmacist shall submit a submission for re-certification to the certification authority two months prior to the expiry of the period of validity of the certificate (Annex 1). The following documents shall be appended to the application:

10.1. a statement issued by an employer attesting to professional activity in the specialty within the last three years;

10.2. an opinion issued by the family doctor regarding the conformity of his or her state of health with the work to be performed;

10.3. a copy of the passport, if the passport has been changed during the period of validity of the certificate;

10.4. two photographs (3.5 x 4.5 cm);

10.5. copies of documents attesting to the improvement of professional qualification;

10.6. report on the improvement of professional qualification in further education activities.

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11. The Certification Commission shall review the documents referred to in Paragraph 10 of this Regulation submitted by the certified pharmacist which attest to the pharmaceutical activity and improvement of professional qualification performed during the period of validity of the previous certificate.

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12. If the Certification Commission accepts the attestation of professional activity referred to in Paragraph 11 of this Regulation and the improvement of professional qualification complies with the further education process recognised by the Latvian Pharmacist Association, the pharmacist to be re-certified shall receive a certificate repeatedly without taking the certification examination.

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13. If the Certification Commission does not accept the attestation of professional activity referred to in Paragraph 11 of this Regulation and the improvement of professional qualification does not comply with the further education process recognised by the Latvian Pharmacist Association, and a re-certification is refused, the pharmacist to be re-certified shall take a certification examination and acquire a certificate in accordance with the procedures specified in this Regulation.

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14. The certificate shall indicate the following information:

14.1. the full name of the certification authority;

14.2. the given name, surname and personal identity number of the certified person;

14.3. laws and regulations in accordance with which the certificate has been acquired;

14.4. the date of granting the certificate;

14.5. the period of validity of the certificate;

14.6. the certificate number.

15. The certificate shall be signed by the head of the certification authority and it shall be approved by the seal of the certification authority.

16. A sample of the certificate-tag of a certified pharmacist is indicated in Annex 2 to this Regulation.

17. The certificate shall be re-registered if a submission of the certified person has been received regarding:

17.1. the loss of the certificate;

17.2. the change of the given name or surname of the certified person.

IV. Withdrawal of the Certificate

18. The Certification Commission may take a decision regarding the withdrawal of the certificate if:

18.1. the certified pharmacist has violated the laws and regulations governing pharmaceutical activities and other laws and regulations;

18.2. the submission of a certified person has been received;

18.3. after granting of the certificate it is discovered that the documents submitted for certification have been forged or contain false information.

19. A proposal regarding the withdrawal of the certificate may be submitted to the certification authority by:

19.1. the Ministry of Health;

19.2. the Health Inspectorate;

19.3. the Latvian Pharmacist Association.

20. The certification authority shall notify in writing regarding a decision regarding the withdrawal of the certificate:

20.1. the pharmacist whose certificate is being withdrawn;

20.2. the Health Inspectorate;

20.3. the State Agency of Medicines.

V. Rights and Duties of the Pharmacist to be Certified

21. The pharmacist to be certified is entitled to:

21.1. become acquainted with the criteria for certification, as well as the provisions of the certification examination;

21.2. take a certification examination within four months after submitting the submission;

21.3. receive information regarding the place and time of the certification examination not later than two months prior to the referred to examination;

21.4. become acquainted with the evaluation system for the certification examination and, within three days after taking the examination, receive information regarding the results thereof;

21.5. become acquainted with the personnel of the certification examination commission and submit justified objections against nominations of separate members of the examination commission to the chairperson of the Certification Commission;

21.6. submit objections to the head of the certification authority regarding the procedure or evaluation of the certification examination, as well as to dispute the decision of the Certification Commission regarding the withdrawal of the certificate.

22. A certified pharmacist, when fulfilling work duties, shall attach the certificate-tag to his or her clothing in a visible place.

23. A pharmacist whose certificate has been withdrawn shall, within three working days after receipt of the written notification, hand over the withdrawn certificate and the certificate-tag to the certification authority.

24. A decision of the certification authority may be appealed in court in accordance with the procedures prescribed by the Administrative Procedure Law.

VI. Closing Provisions

25. Cabinet Regulation No. 248 of 6 July 1999, Procedures for the Certification of Professional Qualification of Pharmacists (Latvijas Vēstnesis, 1999, No. 224/226; 2003, No. 167), is repealed.

26. Certificates which have been issued in accordance with Cabinet Regulation No. 248 of 6 July 1999, Procedures for the Certification of Professional Qualification of Pharmacists, shall be in effect until the expiry of the period of validity thereof.

27. The pharmacists who have received certificates in accordance with the Cabinet Regulation No. 248 of 6 July 1999, Procedures for the Certification of Professional Qualification of Pharmacists, shall be re-certified after expiry of the period of validity of the certificate in accordance with the procedures specified in this Regulation.

28. The accreditation of the certification authority which has been performed in accordance with the requirements specified in the standard LVS EN ISO/IEC 17024:2005 "Conformity assessment. General requirements for bodies operating certification of persons" in the State limited liability company "Standardisation, Accreditation and Metrology Centre" in the National Accreditation Bureau of Latvia by the date of coming into force of this Regulation shall be valid until the end of the accreditation term.

29. This Regulation shall come into force on 1 April 2010.

Prime Minister V. Dombrovskis

Minister for the Interior
Acting for the Minister for Health L. Mūrniece

Annex 1
Cabinet Regulation No. 290
23 March 2010

Submission for the Receipt of the Professional Qualification Certificate of the Pharmacist

[21 January 2014]

__________________________________
(name of the certification authority)

To the Professional Qualification Certification Commission of Pharmacists

To be completed by the Professional Qualification Certification Commission of Pharmacists

Received __________ No.________

Meeting No. ____of the Certification Commission ________ ________

Meeting No. ____of the Certification Examination Commission ________ ________

Meeting No. ____of the Certification Commission ________

Certificate No. ___________

Note. The details of the document "signature" and "date" shall not be completed if the electronic document has been drawn up in conformity with the laws and regulations regarding drawing up of electronic documents.

Minister for the Interior
Acting for the Minister for Health L. Mūrniece

Annex 2
Cabinet Regulation No. 290
23 March 2010

Certificate-Tag of the Certified Pharmacist

1. Front of the certificate-tag

No. _______

2. Back of the certificate-tag

Minister for the Interior
Acting for the Minister for Health L. Mūrniece

Translation © 2018 Valsts valodas centrs (State Language Centre)