Published: 2010-04-24
Key Benefits:
Passed 17.02.2005 Annex 24
RTL 2005, 22, 305
Entry into force 01.03.2005
| 26.02.2010 | RTL 2010, 10, 180 | 01.04.2010 |
| 15.04.2010 | RTL 2010, 20, 365 | 24.04.2010 |
This Regulation is established on the basis of clause 31 (6) 3) of the Medicinal Products Act.
This Regulation establishes the requirements for the facilities, installations, technical equipment, staff and organisation of work in a general pharmacy, veterinary pharmacy and hospital pharmacy and their branch pharmacies (hereinafter the pharmacy), as well as recording of medicinal products and reporting.
(1) A pharmacy shall have at least the following facilities:
1) sales area;
2) preparation rooms (where the pharmacy prepares or divides-up medicinal products into packages);
3) storage room(s) (if necessary);
4) staff room(s);
5) toilet.
(2) Preparation rooms comprise an auxiliary room, a washing room and a sterilisation section, as well as a dividing-up room in pharmacies with no obligation to prepare medicinal products and veterinary pharmacies.
(3) The sterilisation section is composed of an airlock, auxiliary room of the sterilisation section and a sterilisation room.
(4) Where a pharmacy has the obligation to prepare medicinal products, the pharmacy shall have an auxiliary room and a washing room.
(5) Where a general pharmacy or veterinary pharmacy with no obligation to prepare medicinal products divides up medicinal products into packages, the pharmacy shall have a dividing-up room and a washing room. The washing room may form a part of the dividing-up room.
(6) A pharmacy may be located in a residential building, provided that the entrance to the pharmacy is separated from the residents’ entrance. Pharmacies located in rural areas may share an entrance with the residents upon the written consent of all apartment owners or the general meeting of the apartment association.
(7) Where the pharmacy is located higher than the first floor, visitors must have the option of using the elevator.
(8) The pharmacy facilities shall be separated from the surrounding area by floor-to-ceiling partition walls. The sales area, preparation rooms and storage room(s) shall be located within an ensemble. The ensemble shall accommodate at least one staff room or a separated section for the workstation of the head of pharmacy and a place for storage of documents. A pharmacy may have separate additional rooms for the
staff as well as for storage of archives, tools, tare and other items not required for the everyday work of a pharmacy.
(9) The floor of the sales area and preparation rooms shall not be lower than half the height of the room below ground level. The staff, storage and additional rooms may be located in the basement.
(10) Pharmacy facilities shall be used for the intended purpose.
(11) The rooms and hallways of a pharmacy shall only be accessible for the staff of the pharmacy. Unauthorised parties shall not be allowed access to the preparation and storage rooms.
(12) The layout plan of the pharmacy shall be submitted to the State Agency of Medicines for review prior to the launch of construction or change of layout.
(1) A sales area is a separate room or a separated section for serving visitors. The sales area shall be fitted with the furniture required for serving visitors and storing medicinal products. The fittings shall be laid out in such a way that an employee would not have to pass through the visitor section of the sales area for gaining access to other pharmacy facilities from the sales area.
(2) In a hospital pharmacy, the sales area shall consist of a room or a separated section for accepting orders, for storing medicinal products prepared for dispensing to the departments, and for dispensing the medicinal products. The above room or section shall not be used as a storage room.
(1) Preparation rooms must be completely separated from other facilities via walls and doors. The auxiliary room, auxiliary room of the sterilisation section, dividing-up room and washing room shall not allow pass-through.
(2) The auxiliary room may only be used for preparation, dividing-up and inspection of medicinal products.
(3) The dividing-up room may only be used for dividing up medicinal products into packages, and, if necessary, for washing pharmacy utensils.
(4) The washing room may only be used for washing and sterilising pharmacy utensils.
(5) The auxiliary room, washing room and dividing-up room may also be used for cleaning (distilling) and testing water.
(6) The windows and doors of preparation rooms must be kept closed at all times.
Storage room(s) is/are separate room(s) or separated section(s) that enable to establish the conditions required for appropriate storage of medicinal products.
Staff rooms are designed for storing documents, outerwear and staff uniforms, as well as for lunch and recreation, if necessary.
(1) A general pharmacy shall have a minimum area of 80 m2 in a city and 50 m2 in a rural area.
(2) A branch pharmacy of a general pharmacy shall have a minimum area of 45 m2 in a city and 25 m2 in a rural area. If a branch pharmacy prepares or divides up medicinal products into packages, the requirements for the area of the general pharmacy shall apply to the branch pharmacy.
(3) In exceptional cases, the minimum area of a general pharmacy located in a rural area may be 40 m2, if the pharmacy is located at a distance of more than 10 km from the nearest pharmacy or if the transport connection to the nearest pharmacy is poor, provided that the quality of the service provided by the pharmacy does not deteriorate due to the smaller area.
(4) In exceptional cases, the minimum area of a branch pharmacy of a general pharmacy located in a rural area may be 15 m2, if the pharmacy is located at a distance of more than 10 km from the nearest pharmacy
or if the transport connection to the nearest pharmacy is poor, provided that the quality of the service provided by the pharmacy does not deteriorate due to the smaller area.
(5) If a veterinary pharmacy or its branch pharmacy divides up medicinal products into packages, the pharmacy shall have a minimum area of 50 m2. A veterinary pharmacy or its branch pharmacy shall have a minimum area of 30 m2, if the pharmacy does not divide up medicinal products into packages.
(6) The minimum area consists of the area of the rooms located within an ensemble.
(1) The minimum area of the sales area shall be:
1) 30 m2 in a general pharmacy located in a city;
2) 20 m2 in a general pharmacy located in a rural area;
3) 15 m2 in a veterinary pharmacy and its branch pharmacy;
4) 25 m2 in a branch pharmacy of a general pharmacy located in a city;
5) 15 m2 in a branch pharmacy of a general pharmacy located in a rural area, except in the case stipulated in subsection 7 (4).
(2) The minimum area of the preparation rooms shall be:
1) 5 m2 for an auxiliary room;
2) 4 m2 for a washing room;
3) 5 m2 for a dividing-up room and 9 m2 if the washing room forms a part of the dividing-up room;
4) 3 m2 for the airlock, 5 m2 for the auxiliary room and 8 m2 for the sterilisation room of the sterilisation section.
(3) The requirements established for preparation rooms shall apply to hospital pharmacies.
In order to comply with the requirements arising from legal acts regulating the handling of medicinal products, a pharmacy shall have:
1) the fittings, tools and equipment, as needed;
2) security measures (including a security alarm system);
3) telephone.
(1) The work of a pharmacy, including branch pharmacies, is managed and supervised by the head of a general pharmacy, hospital pharmacy or veterinary pharmacy (hereinafter the main pharmacy).
(2) The head of a main pharmacy shall assign in writing his or her replacement(s), except if no other employees with a professional education are available in the pharmacy.
(3) The head of a main pharmacy shall assign a person responsible for the activities of the branch pharmacy, who must have education in the field of pharmacy; a person responsible for the branch pharmacy of a veterinary pharmacy may also have the education of a veterinarian.
(4) A job description shall be prepared for all employees of a pharmacy. A job description is a written document in which the head of pharmacy establishes the employee’s duties and sphere of responsibility.
(1) Information on the name and business hours of the pharmacy shall be displayed in front of the entrance to the pharmacy. In a branch pharmacy, the information shall include the business hours and a reference that the pharmacy is a branch pharmacy, specifying the name of the general pharmacy or veterinary pharmacy which formed the branch pharmacy.
(2) Where a pharmacy is open 24 hours a day in a city or rural area, a notice shall be displayed, specifying the name and location of the pharmacy.
(3) The State Agency of Medicines shall be immediately notified of any changes in the business hours or contact data of a pharmacy (telephone, fax, e-mail address).
(4) In case of closure, including temporary closure, of a general pharmacy or veterinary pharmacy or their branch pharmacy, the written notice to consumers shall contain information on the duration of closure of the pharmacy as well as the location and business hours of the nearest pharmacy or pharmacies.
(5) The State Agency of Medicines and consumers shall be notified at least five days in advance of any scheduled closure of a pharmacy for more than one week.
(6) The State Agency of Medicines shall be notified of any forced entries to the pharmacy, theft or loss of medicinal products or prescriptions or counterfeit or presumably counterfeit medicinal products and prescriptions.
(7) Subsections (3), (5) and (6) of this Section shall be applied to the organisation of work in a hospital pharmacy.
(1) All employees of a pharmacy shall have a name-tag, containing the name and (in case of a professional education) position (dispensing chemist, pharmacist, veterinarian) of the employee. The status of a trainee shall be separately specified.
(2) Pharmacologically classified medicinal products not subject to medical prescription may be displayed in the sales area. Medicinal products subject to medical prescription shall not be displayed to visitors.
(3) Where veterinary medicinal products are dispensed by a veterinarian in the pharmacy, the veterinarian shall have a separate point of sale, which is marked accordingly.
(4) A veterinarian shall receive medicinal products for human use, dispensed for veterinary use, from the dispensing chemist or pharmacist.
(5) Medicinal products dispensed for veterinary use shall be marked with the words „ Ainult veterinaarseks kasutamiseks ” [for veterinary use only]. For the above marking, a printed sticker or a stamp may be used, which shall not cover the important information on the original labelling, required for identification of the medicinal product, including the batch number and shelf life.
(6) Where a medicinal product subject to medical prescription is issued by a trainee, the prescription or delivery note shall contain, in addition to the signature of the trainee, the signature of his or her supervisor.
(7) Where additional activities are required for administration of a medicinal product (e.g. dissolving), the person dispensing the medicinal product shall explain this to the buyer of the medicinal product, offer the corresponding service and, if the customer so desires, prepare the medicinal product for administration.
(8) A pharmacy shall document any complaints filed with respect to medicinal products, specifying the data on the person filing the complaint, the medicinal product, the nature of the complaint and circumstances related to the complaint. The process of settlement of the complaint in the pharmacy shall be documented.
(9) Medicinal products prepared or divided up into packages in a general pharmacy or veterinary pharmacy may be dispensed for the purpose of forward selling to the branch pharmacy, as well as, on the basis of a prescription or an order form of a health care provider, to a pharmacy with no obligation to prepare medicinal products. On the basis of a prescription or an order form of a health care provider, sterile medicinal products prepared by a pharmacy may also be dispensed for the purpose of forward selling to a pharmacy not authorised to prepare sterile medicinal products.
(10) A pharmacy with no obligation to prepare medicinal products, including a branch pharmacy, shall accept a prescription or an order form of a health care provider for preparation of a medicinal product as magistral formula, and forward a copy thereof to the general pharmacy with the obligation to prepare medicinal products. If a pharmacy is not authorised to prepare sterile medicinal products, the pharmacy shall forward a copy of the prescription or order form to a pharmacy with the authorisation to prepare sterile medicinal products.
(11) The pharmacy preparing the medicinal products shall dispense the medicinal product together with an accompanying document, which shall contain at least the following information:
1) name and address of the pharmacy ordering the medicinal product;
2) name and address of the pharmacy preparing the medicinal product;
3) number of the prescription, and number or date of issue of the order form;
4) date of dispensing of the medicinal product;
5) price of the medicinal product;
6) signatures of the persons dispensing and receiving the medicinal product.
(12) Subsections (1), (5), (6), (8), (9), (10) and (11) of this Section shall be applied to the activities of a hospital pharmacy.
(1) All pharmacies and branch pharmacies shall establish written internal work procedure rules for activities affecting the quality of and related to the handling of medicinal products.
(2) The work procedure rules shall describe in detail the following activities, documenting of activities and preservation of the documentation:
1) ordering of medicinal products;
2) receipt of medicinal products, including pricing;
3) storage of medicinal products and inspection of the storage conditions;
4) restriction of third-party access to medicinal products;
5) handling of narcotic drugs and psychotropic substances as well as medicinal products containing such substances;
6) preparation of and dividing-up of medicinal products into packages;
7) quality control of the medicinal products prepared;
8) preparation and testing of clean water;
9) washing and sterilising of pharmacy utensils;
10) ordering of medicinal products, including ordering of medicinal products on the basis of the requests of doctors;
11) dispensing of medicinal products, including dispensing of unauthorised medicinal products and dispensing on the basis of order forms;
12) dispensing of medicinal products to branch pharmacies, including organisation of transport;
13) withdrawing of medicinal products from the market and further handling of medicinal products, including handling of medicinal products received from consumers for destruction;
14) suspension or termination of dispensation of medicinal products and recalling of medicinal products;
15) handling of returned medicinal products;
16) recording of medicinal products and reporting;
17) adherence by the pharmacy to health protection requirements, including cleaning and maintenance of pharmacy facilities and equipment;
18) pest control in the pharmacy facilities;
19) processing of complaints;
20) displaying of advertisements of medicinal products in the pharmacy facilities;
21) internal audit.
(3) The work procedure rules may also specify other activities related to the handling of medicinal products not stipulated in subsection (2) of this Section.
(4) The work procedure rules shall be up-to-date and be dated and signed by the head of pharmacy. Previous versions of the work procedure rules shall be preserved for a period of at least five years.
(5) The head of a main pharmacy shall assign in writing a person responsible for each activity, and a replacement for the person, except if the pharmacy only has a single employee with the requisite education for the provision of pharmacy services.
(6) Employees shall be familiar with the work procedure rules and legal acts providing the basis for their duties. Legal acts regulating medicinal products and the work procedure rules shall be available to the employee at the pharmacy at any time.
(7) Employee shall confirm being familiar with the work procedure rules and legal acts by giving the date and signature.
(1) The documentation stipulated in legal acts regulating medicinal products shall be prepared during the execution of or immediately after completion of the activity, unless otherwise specified in the corresponding legal act.
(2) Any amendments to the documentation shall be dated and signed by the person introducing the amendment, retaining the original entry, and providing the reason for the amendment, where applicable.
(3) The requirements stipulated in subsections (1) and (2) shall also be followed in electronic documenting.
(1) A separate place shall be established for the purpose of receipt of medicinal products.
(2) A pharmacy shall assign in writing the persons authorised to conduct delivery inspection and pricing. (3) A delivery inspection shall be conducted upon delivery of medicinal products, specifying the following:
1) the existence, form and compliance of the accompanying documents and, if necessary, quality verification documents (quality certificates) with the batch;
2) compliance of the number of packages and labelling with the accompanying documents;
3) shelf life;
4) storage conditions;
5) existence of information in Estonian (information in Estonian on the outer package and the package leaflet).
(4) The inspector shall date and sign the accompanying document or instrument of delivery and receipt of the goods to verify performance of the delivery inspection.
(5) The starting materials used for the preparation or dividing-up of medicinal products into packages shall come with a quality certificate. The State Agency of Medicines shall be immediately notified of any doubts regarding the quality or identity of the starting materials. In such cases, the starting materials may only be used on the permission of the State Agency of Medicines.
(6) A pharmacy shall not accept medicinal products for dispensing from persons who do not hold an activity licence for the manufacture of medicinal products, wholesale trade of medicinal products, or provision of pharmacy services.
(7) Unpackaged herbal substances may also be purchased from other individuals beside those holding an activity licence specified in subsection (6). In such cases, the pharmacy shall be responsible for the quality of the herbal substances.
(8) The purchase and sales prices of medicinal products shall be documented on paper, and bear the date and signature of the pharmacy employee who carried out the pricing or inspection. This requirement shall not apply to hospital pharmacies.
(1) As of the moment of the receipt of medicinal products by a pharmacy, the pharmacy shall be responsible for the preservation of the quality of the medicinal products.
(2) Medicinal products shall be stored pursuant to the procedure established on the basis of subsection 34 (5) of the Medicinal Products Act.
(3) Medicinal products which are only allowed to be dispensed on the request of a doctor or veterinarian and other unauthorised medicinal products shall be stored separately, marked accordingly or by implementing other efficient measures to ensure distinguishability.
(1) Upon discovering defective medicinal products, the defects shall be documented by registering the data on the medicinal product, marketing authorisation holder, intermediator, nature of the defect, circumstances related to the defect or the cause of the defect and further handling (storage, destruction return to the supplier etc) of the defective medicinal product.
(2) The State Agency of Medicines shall be immediately notified of any defective or presumably defective medicinal products discovered in a pharmacy. No notice is required, if it has become evident that the defect is caused by faulty handling on behalf of the pharmacy or during transportation.
(1) A pharmacy shall establish a system for suspension or termination of dispensation of medicinal products or recalling of dispensed medicinal products (hereinafter restriction on dispensing) in cases where:
1) the medicinal product is defective or is presumed to be defective;
2) the wrong or expired medicinal product was dispensed;
3) the corresponding order is given by the State Agency of Medicines, manufacturer of the medicinal product, wholesaler or marketing authorisation holder.
(2) The State Agency of Medicines shall be immediately notified of any restriction on dispensing initiated by the pharmacy.
(3) Recalled medicinal products and medicinal products the dispensing of which has been suspended shall be identified and stored separately, preventing their dispensing until further notice regarding their handling.
(4) The restriction on dispensing shall be documented, including specification of the reason for the restriction on dispensing and further action, and a list shall be prepared of persons notified of the restriction. The stock of the medicinal product in the pharmacy and branch pharmacy shall be registered as of the moment of the establishment of the restriction on dispensing, and the recall organised as required. The data contained in the documentation shall enable identification of the medicinal product.
(1) At least once a year, a pharmacy shall conduct internal audits to monitor implementation of and compliance with the requirements established by legal acts and adherence to work procedure rules and job descriptions in pharmacies and branch pharmacies, and to make proposals on taking measures.
(2) The internal audit shall be prepared as a report. The report shall specify the audit findings and the proposals for taking measures. The auditors shall date and sign the report.
(3) Once a year, a pharmacy shall conduct inventory of the medicinal products, specifying in the inventory report the name of the medicinal product, content of active substance, quantity in packaging, and number of packages. The results of the inventory shall be submitted to the State Agency of Medicines upon its request.
(4) Data on the last inventory shall be available on site at the pharmacy or branch pharmacy.
(1) Documents registering the receipt, dispensing and recording of medicinal products and their source documents (delivery notes, quality certificates, etc.) as well as prescriptions shall be available on site at the pharmacy or branch pharmacy at least until completion of the marketing of the batch.
(2) The documents specified in subsection (1) shall be preserved by the pharmacy for at least two years after the date of dispensing of the medicinal product.
(3) Accompanying documents received in electronic form from the wholesaler may be preserved in electronic form, provided that a hard copy of the instrument of delivery and receipt of the goods is available, specifying the data stipulated in the wholesale accompanying document. Accompanying documents forwarded in electronic form shall be available on site at the pharmacy and shall be reproducible.
(4) Where a branch pharmacy orders goods directly from a wholesaler, copies of the accompanying documents shall also be available at the main pharmacy, separated from the accompanying documents of the main pharmacy. The accompanying documents forwarded to a branch pharmacy by the wholesaler in electronic form may also be available at the main pharmacy in electronic form.
(1) A prescription record shall be kept of the dispensing of medicinal products subject to medical prescription by a general pharmacy and veterinary pharmacy, containing the following information:
1) number of the prescription or registry number of the prescription assigned by the pharmacy, or both;
2) name of patient, name of the owner of the animal in case of a veterinary medicinal product;
3) name of the medicinal product dispensed;
4) content of active substance;
5) quantity in packaging and number of packages;
6) retail price of the medicinal product;
7) date of dispensing.
(2) Data on the dispensing of the medicinal product shall be recorded immediately upon dispensing of the medicinal product by the person dispensing the medicinal product.
(3) A record shall be kept of unauthorised medicinal products. A record shall be kept of the receipt of unauthorised medicinal products (name of medicinal product, quantity, supplier, date of receipt). The record may be kept in electronic form or on paper. Prescriptions and order forms of unauthorised medicinal products shall be stored separately from the prescriptions and order forms of other medicinal products in a general pharmacy and veterinary pharmacy as well as their branch pharmacy. In case of prescriptions issued at a discount rate, a copy shall be made of the prescription, or the number and date of issue of the prescription entered in the record.
(4) A record shall be kept of all medicinal products in a hospital pharmacy. If no electronic record is kept, a record shall be kept on the basis of the receipt and dispensing documents on the medicinal product.
A record of the receipt and dispensing of narcotic drugs and psychotropic substances and medicinal products containing such substances shall be kept by a pharmacy pursuant to the procedure provided by legal acts regulating the handling of narcotic drugs and psychotropic substances.
The recording of medicinal products prepared as officinal formulae, dividing-up of medicinal products into packages, medicinal products prepared as magistral formulae and quality control shall be carried out pursuant to the procedure provided in clause 31 (6) 1) of the Medicinal Products Act.
(1) A pharmacy shall keep a record of medicinal products withdrawn from the market. (2) The record shall contain the following information:
1) name of the medicinal product;
2) content of active substance;
3) package size;
4) number of packages;
5) marketing authorisation holder or, if no marketing authorisation holder is available, manufacturer of the medicinal product;
6) batch number;
7) reason for withdrawal from the market.
(1) A pharmacy shall keep a record of medicinal products received as foreign aid
(2) The record shall contain the following information:
1) name of the medicinal product;
2) content of active substance;
3) package size;
4) number of packages;
5) manufacturer;
6) batch number;
7) supplier;
8) date of receipt.
(3) The accompanying documents regarding the receipt and dispensing of medicinal products received as foreign aid shall be preserved separately from the accompanying documents of other medicinal products.
(1) A main pharmacy shall submit a report to the State Agency of Medicines four times a year.
(2) The reports shall be submitted to the State Agency of Medicines as follows:
1) the report on the first quarter by May 1 (reporting period: January 1 – March 31);
2) the report on the second quarter by August 1 (reporting period: April 1 – June 30);
3) the report on the third quarter by November 1 (reporting period: July 1 – September 30);
4) the report on the fourth quarter by February 1 (reporting period: October 1 – December 31).
(1) A report on a general pharmacy shall contain the following information in the below order:
1) total turnover of the pharmacy;
2) total turnover of medicinal products, including separately the turnover of medicinal products for human use, not subject to medical prescription, turnover of medicinal products for human use, subject to medical prescription, turnover of medicinal products issued in a Member State of the European Union, a Member State of the European Economic Area or the Swiss Confederation (hereinafter EU prescription) and turnover of veterinary medicinal products;
[RTL 2010, 10, 180 – entered into force 01.04.2010]
3) turnover of medicinal products dispensed at a discount rate, including separately the portions paid by the patient and the Estonian Health Insurance Fund;
4) turnover of medicinal products sold to institutions, including separately the turnover of medicinal products sold to health care providers and social welfare institutions and other institutions;
5) number of prescriptions, including separately the number of prescriptions issued at a discount rate, number of prescriptions issued without a discount rate, number of prescriptions of and order forms for medicinal products prepared as magistral formulae and number of veterinary prescriptions; [RTL 2010, 10, 180 – entered into force 01.04.2010]
6) preparation and dividing-up of medicinal products into packages, including separately the number of packages of medicinal products prepared as officinal formulae, number of packages received upon dividing-up, the fee for the preparation of medicinal products and the fee for the dividing-up of medicinal products into packages;
7) the purchase price of medicinal products sold;
8) data on employees as of the end of the reporting period, including separately the number of dispensing chemists, pharmacists, veterinarians and other employees.
(2) A report on a hospital pharmacy shall contain the following information in the below order:
1) total turnover of the pharmacy;
2) total turnover of medicinal products;
3) turnover of medicinal products sold outside the hospital operating the hospital pharmacy;
4) data on employees as of the end of the reporting period, including separately the number of dispensing chemists, pharmacists and other employees.
(3) A report on a veterinary pharmacy shall contain the following information in the below order:
1) total turnover of the pharmacy;
2) total turnover of medicinal products, including separately the turnover of medicinal products not subject to medical prescription and medicinal products subject to medical prescription;
3) turnover of medicinal products sold to institutions, including separately the turnover of medicinal products sold to veterinarians;
4) number of prescriptions;
5) dividing-up of medicinal products into packages, including the number of divided-up packages and the fee for the dividing-up;
6) the purchase price of medicinal products sold;
7) data on employees as of the end of the reporting period, including separately the number of veterinarians, dispensing chemists, pharmacists and other employees.
(1) The report shall be submitted to the State Agency of Medicines on a hard copy, signed by the head of main pharmacy. Where possible, the report shall also be submitted to the State Agency of Medicines in electronic form.
(2) The State Agency of Medicines shall publish the report form and the guidelines for filling out the report form on its website.
(1) Upon dissolution of the holder of activity licence for provision of pharmacy services or termination of the activities specified in the activity licence, the medicinal products held by the pharmacy shall be delivered to the holder of activity licence for handling of medicinal products or the person stipulated in subsection 33 (2) of the Medicinal Products Act, or withdrawn from the market within two months after the date of dissolution, unless otherwise established by the State Agency of Medicines, by informing the State Agency of Medicines in writing thereof.
[RTL 2010, 20, 365 – entered into force 24.04.2010]
(2) Upon termination of the provision of pharmacy services, the head of pharmacy shall be responsible for maintaining the quality of the medicinal products until completion of delivery (including delivery for destruction), on-site destruction or returning of the medicinal products, and the holder of the activity licence for provision of pharmacy services or a person appointed by the holder shall be responsible for the preservation of the corresponding accompanying documents.
(3) Upon completion of delivery of medicinal products, a report shall be prepared for the State Agency of Medicines on the period following the last quarterly report pursuant to the procedure provided in section 27.
(1) The requirements stipulated in subsections 2 (1)-(9), subsection 4 (1), subsection 7 (5), clause 8 (1) 3) and subsection 8 (2) shall be implemented for veterinary pharmacies operating before the entry into force of this Regulation from 1 March 2006 onwards.
(2) The requirements stipulated in subsection 3 (2) of the Regulation shall be implemented for hospital pharmacies operating before the entry into force of this Regulation from 1 March 2006 onwards.
