Licensing of Pharmacy Practice: Ensuring Medication Safety and Quality Assurance

1. Unit 2. LICENSING IN PHARMACY

2. The practice of pharmacy within each state is regulated by the laws of the state, deluding the regulation of licensure for pharmacy practice. Licensing is foreseen in Ukraine for the government control. The aim of licensing and standards is to protect public health by ensuring that medicines and medical devices meet definable standards of quality assurance and are manufactured in conditions that are clean and free of contaminants.

4. To practice pharmacy in any state, a pharmacist must become a registered pharmacist (RPh), also known as a licensed pharmacist. Pharmacists are licensed by the State Board of Pharmacy. Requirements vary somewhat from state to state, but in general, to be licensed a pharmacist must: • Graduate from an accredited college of pharmacy • Participate in residency or internship programs to acquire direct, "hands-on" patient care experience

5. « Pass a rigorous examination, known as the NABPLEX (National Association of Boards of Pharmacy Licensing Examination) : The pharmacist's educational experience does not end upon being licensed.; Most states require licensed pharmacists to take continuing education courses every year in order to maintain their licenses to practice. Pharmacists obtain this additional education through correspondence courses, attending professional meetings and seminars presented by pharmacy associations, or participating in courses provided by the schools and colleges of pharmacy. *| Licensing of the Pharmaceutical Activities of Pharmacy Establishments

6. A license is the document of state standard which confirms the right of licensee to introduction of economic activity for certain term on conditions of implementation of the licensed terms. A licensee is a management subject getting a license to realization of definite type of economic activity, subject to licensing.

7. APPROVED Order of the State Inspection Quality Control drugs Ministry of Health of Ukraine 21.09.2010 N 340 LICENSEbusiness activity Drug Manufacturing, wholesale, retail pharmaceuticals Head of State service of medical means – Oleksij Solovjov

8. By law, subject to licensing: • production; • wholesale drugs; • retail trade in drugs.

9. State service of medical means decides to grant a license or refusal to issue in time no later than ten working days from the date of application for a license and documents attached to the application. 13. About the decision to grant a license or denial of the license is sent (issued) applicant in writing within three working days from the date decision.

10. The reasons for the decision to refuse licenses are: invalidate the data in documents filed by the applicant for license;      discrepancy the applicant in accordance with the submitted documents License terms set for the type of business activities specified in the license application.      In case of refusal to issue a license based on the detection false data in documents submitted by the applicant on the grant license, the entity may submit to State service of medical means new license application no earlier than three months the date of the decision refusing to issue a license.

11. In case of refusal to issue a license based on the discrepancy applicant's license conditions set for the type of business activities specified in the license application, subject entity may submit to the Ministry of Health State service of medical means new application for license as the reason for that became the basis for refusal to issue the license.

12. License issued to the applicant personally or by his authorized person no later than three business days after receipt document confirming payment of license fee. If the applicant within thirty calendar days sending him a message about the decision to grant license did not submit the document confirming payment of license, or not addressed to State service of medical means executed a license, then State service of medical means which formalized license has the right to terminate the license or decide on the recognition of such a license.

13. Licensing is registered in the numbered laced, and the sealed book of applications and issued licenses in the prescribed form (Annex 3). Journal of statements and issued licenses conducted separately for each type of business activities subject to licensing. For each place where the separated unit that fight economic activity based on obtained a license, issued licensee State service of medical means certified copy of his license which is registered in the logbook applications and issued licenses.

15. In case of liquidation separate unit licensee who has led the business activities in accordance with the received license, or in case of a separate proceeding licensee's business unit in accordance with the received license the licensee shall, within seven working days from the date eliminating separate unit or from the date of termination of a separate unit submit an notice in writing to State service of medical means or send it by registered mail.      

17. If you have any grounds for license renewal licensee shall, within ten working days to submit State service of medical means license renewal application (Annex 5) along with the license to be reissued, and relevant documents or notarized copies, which confirm these changes. A licensee who has submitted an application for license renewal and related documents may be operating at basis of the certificate of adoption of the above documents to review issued State service of medical means.      In case of loss or damage to license the licensee shall apply to the Ministry of Health State service of medical means a statement about issuance of duplicate licenses (Appendix 6).

19. In wholesale and retail drugs allowed only registered in Ukraine drugs, if the quality certificate issued manufacturer. In the case of storage in the form of certificates of quality scanned copies of certificates licensee must provide them paper copies (on demand), stamped subject shall, not later than within two days.      Trade or substandard medicines such term life has expired or for which no certificate of quality given manufacturer, is prohibited.       Trade remedies, made from pharmacy violations of conditions of production, is prohibited.       The entity must keep the certificates as a producer (on paper copies or scanned copies electronic media) on a series of pharmaceutical products sold entity within three years.

21. 1.11. The facade of the building, where the pharmacies, according to its intended to be a sign indicating the names of institutions ("Pharmaceutical composition (base), Pharmacy, "Drugstore", "Pharmaceutical stand") that is not considered advertising. Near the entrance to the pharmacy school located in a prominent place information about the entity and the owner or authorized body, work pharmaceutical establishment. For pharmacies and their divisions are legally required information indicating the next address (hours) and the nearest pharmacy. Not in the locations of structural units Pharmacies put the sign "Pharmacy on the pharmacy - Pharmacy staff and other information does not match the information specified in the license, in including as advertising.      If desired, the licensee may install an alarm indicator, which is not considered advertising.

25. 1.12. Pharmacies must have its own name or number.      1.13. Pharmacies have the right to buy and sell except medicines, related products list for that determined by the MOH.      1.14. Licensee must notify State service of medical means of all changes in data specified in the documents attached to application for a license. In the event of such changes, the licensee shall, within ten working days to submit to the authority Licensing a notification in writing together with documents or their copies confirming these changes prescribed by legislation.

26. 2. Special requirements 2.4. In wholesale trade remedies:      2.4.1. Wholesale drugs is through the pharmacy database (warehouse). Manufacturers of medicines carry out the implementation of its own products based on license to manufacture drugs.      The licensee must provide:      purchase and sale only medicines that incorporated under the laws of Ukraine;      compliance with certain medical conditions of storage manufacturer means (including during transport) and preservation medicines;      prevent contamination of medicines;      operation of detection of any product that does not meets the requirements (technical documentation, analytical and normative documentation of existing standards), and effective procedures for withdrawal.

29. Pharmacy warehouse (base) placed in separate located specially arranged houses in isolated rooms in public buildings and auxiliary buildings industry on any floor (subject to the requirements 02/04/1910 subparagraph of this paragraph) if the arrangement loading and unloading area for the lot entrance (ramp with canopy, etc.) outside the front windows of apartments with a constant stay of people.      For wholesale medical gas pharmacy warehouses (base) must meet the requirements defined by law.

32. Accommodation pharmacy database (staff) in residential buildings, athletic facilities, schools, education and childcare institutions, cultural institutions, sports, education and social security, medical facilities, shops operation is permitted if appropriate separated buildings for other purposes.      2.4.3. Pharmacy warehouse (the base) must be composed of:      production facilities: separate room, area or zone for Acceptance and storage of medications and dispensing them, auxiliary materials and packaging the total area of not less than 250 sq.m. Belong to the production room (zone) in which received, stored medicines room (zone) acquisition and dispensing of medicines (Expeditionary) room (zone) storage auxiliary materials and packaging drug quality control, storage, quarantine products,

34. The composition, location of production facilities and its area should ensure the continuity of a process (receiving, quality control, storage, and dispensing equipment means). If there are drugs that require special storage conditions (Strong, poisonous, narcotic, Psychotropic, immunologic, termolabilni, flammable, flammable, explosive products, herbal and other raw materials) must be properly equipped with separate room (zone) for their storage.

35. The requirement for production area (zones) does not apply on the premises of pharmaceutical warehouses (databases) of business entities wholesale trade only medical gases;      minimum set of household and auxiliary buildings: office staff (0,75 m per worker of one shift, but not less than 8 square meters), restrooms (estimated but not less than 2 meters), space for storage items cleaning (4 meters) or cabinet, depending on a restaurant. To domestic premises also include: wardrobe, shower room, to eat (dining room) and more. In office facilities include:

37. room preparation and processing of supporting documentation, study head, deputy head of cabinet and cabinet personnel participates in the technological process: claims processing customer returns, preparation of documents for process execution acceptance, integration and shipment of products, premises (Zones) for automated manufacturing equipment storage, disinfection facilities for the preparation of solutions and more. To auxiliary facilities include: Camera, archive server, Storage Space for household equipment, rooms health, educational classrooms, etc., and their area is included in the total area of the office-residential premises passport chemist institution. Premises (area) for storing cleaning accessories production facilities and premises (area) of working storage means for handling operations can be in the premises.

38.  Corridors, lobby, staircases, lift shafts, Electrical distribution, boiler, ventkamery (mine) are additional premises.      Accommodation facilities pharmaceutical composition should exclude the need for changing the passage of workers in special through clothing production facilities.       Entry to the household and auxiliary buildings can not conducted through facilities, except Licensing under these conditions.      Quality licensee shall provide a supply drugs to customers within the period agreed between supplier and customer. Good quality of medical facilities must be maintained in the network without the wholesale any changes in their properties to retailers. System traceability as drugs established by the licensee, should ensure detection of any unsafe and counterfeit products.

40. The licensee must have sufficient (depending on capacity institution) of skilled workers. Personnel must meet the qualification requirements set out in Chapter three This section licensing conditions. Management personnel of the pharmacy (Base) where drugs should have sufficient authority, appropriate qualifications and experience to provide proper storage of medicines and treatment.

41. Each pharmacy stock (base) should be appointed at least one authorized person with appropriate authority and is responsible for development, implementation and operation of quality. An authorized person must personally serve duties, have higher pharmaceutical education and work experience for specialty at least two years.      Licensee shall provide the increase on a regular basis staff whose activities may affect the quality products. Facts need training protocol.

42. Licensee shall, within not less than three years save documents confirming the purchase or sale of the date, name, number, expiry date and series received and delivered medicines information buyer (supplier) and details of its license. Must be possible to track the movement of each batch vehicle. Purchase of medicines can be made only in entities that are licensed to manufacture medicines, wholesale drugs.       Issue (sales) drugs may conducted:      entities that have licenses for wholesale trade remedies;      business entities that are licensed to manufacture medicines (for use in production);      business entities that are licensed to retail trade remedies;       directly to health care institutions.

44. PART 2Unit 3. LICENSING IN PHARMACY. 2. Special requirements2.5. In retail trade remedies:

46. Unit 3. LICENSING IN PHARMACY. 2. Special requirements 2.5. In retail trade remedies:      2.5.1. Retail drugs is only through pharmacies and their units (and pharmaceutical items pharmacy), except as provided by law.      2.5.2. In rural areas, in the absence of pharmacy (Structural units) Retail Drug on the list established by order of the Ministry of Health, may be paramedics, medical and obstetric stations, village a district hospitals and dispensaries under the contracts, concluded with an entity that has the appropriate license provided that the vacation will be a person with medical education.

47. 2.5.3. Pharmacies and their units to traders finished product, including manufactured in Pharmacies in the manner prescribed by law.      2.5.4. Do not send out prescription drugs without prescriptions.      You let go without prescription medicines for The list of drugs approved for use in Ukraine, which are sold without prescriptions to pharmacies and their structural subdivisions approved by the Ministry of Health Ukraine from 02.11.2009 N 793 (z1157-09), registered in Ministry of Justice of Ukraine on 01.12.2009 N 1157/17173 (Hereinafter - the List) or under the terms of release as defined in leaflet and / or leaflet / insert these drugs.

48. 2.5.5. In the hall of public service in display cases in glass and open closets (to which no public access), etc. permitted to place medicines sold without prescription, and those for prescription of mandatory marked "Issue a doctor's prescription.

49. 2.5.7. An entity that carries out activities Drug retailers should:      ensure the availability of all necessary facilities, equipment and equipment for proper storage and trade of pharmaceuticals means;      have the required number of staff who is responsible qualification requirements set by Chapter three of this section;      create the necessary conditions for accessibility of persons with disabilities physical abilities to pharmacies.      adhere to certain general and specific manufacturer storage conditions of medicines;

50. have in the hall of public service information on the availability license (copy of license), especially the rules about dispensing drugs address and telephone number of the entity that owns and pharmacy units, address and phone number state agency for consumer protection, address and number of territorial bodies of state control as drugs, as well as book reviews and suggestions, ensure the establishment and functioning information booth or terminal;      ensure that mandatory minimum range of drugs to pharmacies, which is determined Ministry of Health of Ukraine;      comply with the law regarding the control drug quality and have a plan for urgent action removal if needed drugs with implementation;      ensure the safety of medicines;