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Conditions and procedure for preparation, dividing-up and checking of medicinal products in pharmacies, a list of medicinal products prepared as officinal formulae in pharmacies

Content

Conditions and procedure for preparation, dividing-up and checking of medicinal products in pharmacies, a list of medicinal products prepared as officinal formulae in pharmacies - content
Issuer:Minister of Health and Labour
Type:regulation
In force from:12.12.2014
In force until:09.03.2017
Translation published:28.03.2016

Conditions and procedure for preparation, dividing-up and checking of medicinal products in pharmacies, a list of medicinal products prepared as officinal formulae in pharmacies

Passed 03.12.2014 No. 69

This Regulation is established on the basis of clause 31 (6) 1) of the Medicinal Products Act.

Chapter 1 General provisions 

§ 1.  Scope of application

 (1) This Regulation regulates the preparation of medicinal products prepared as magistral formulae, medicinal products prepared as officinal formulae and intermediate products in pharmacies as well as the dividing-up of medicinal products, preparation and chemical testing of purified water and water for injections, washing and sterilisation of pharmacy utensils, documenting of the preparation of and dividing-up of medicinal products, labelling and quality control of the prepared and divided-up medicinal products, documenting of the quality control in pharmacies, submission of the prepared medicinal products for testing, and granting approval for dispensing. The Regulation establishes the expiry dates for medicinal products prepared or divided-up in pharmacies, and the list of medicinal products which are prepared as officinal formulae in pharmacies and are not subject to a medical prescription or order form.

 (2) The requirements set forth in subsection 3 (5), sections 5 and 6, subsection 10 (6) and section 15 of this Regulation shall be applied to the counting-out of medicinal products from packaging.

 (3) The requirements for the dividing-up of medicinal products shall be applied to the personal dividing-up of food supplements in pharmacies.

§ 2.  Terms and definitions

 (1) For the purposes of this Regulation, the term "preparation" refers to any activity related to the preparation of medicinal products in pharmacies: preparation, packaging, dividing-up, labelling and quality control.

 (2) The term "medicinal product prepared as officinal formula" refers to a medicinal product created by means of dividing-up of a fixed quantity of homogeneous mixture that has been divided-up or prepared under similar conditions during a single process of dividing-up or preparation. Medicinal products that have undergone different sterilisation cycles are divided into different series.

 (3) The term "intermediate product" refers to a product prepared in a pharmacy, intended to be used for the preparation of or further dividing-up of medicinal products.

 (4) The term "dividing-up" refers to the dividing-up of the packaging of medicinal products or proprietary medicinal products prepared in a pharmacy into smaller quantities as follows:
 1) the packaging is divided into smaller quantities suitable for dispensing (hereinafter dividing-up from packaging);
 2) the requested quantity of the medicinal product is counted out or weighed out from the packaging on a one-off basis (hereinafter counting-out from packaging);
 3) the packaging is divided into rounds of administration and dispensed to the patient (hereinafter personal dividing-up).

 (5) The term "aseptic preparation" refers to the preparation of a sterile medicinal product without post-preparation sterilisation in a closed final packaging.

 (6) The term "serial number" refers to the number assigned to the process of preparation or dividing-up of a medicinal product prepared as officinal formula, as entered in the preparation or dividing-up documentation.

 (7) The term "primary packaging" refers to the packaging in direct contact with the medicinal product.

 (8) The term "shelf life" refers to the date until which the medicinal product can be administered.

Chapter 2 Preparation and dividing-up of medicinal products 

§ 3.  General requirements

 (1) The manager of a pharmacy shall appoint in writing a person or persons with the right to prepare, divide-up, check and grant approval for dispensing of medicinal products. These persons must have adequate training and practical experience, which shall be documented.

 (2) Medical products prepared as officinal formulae and not subject to a medical prescription or order form may be prepared in a pharmacy only if these medicinal products have been included in the list of medicinal products prepared as officinal formulae, as presented in Annex 1 to this Regulation (hereinafter list of medicinal products prepared as officinal formulae).

 (3) Data on the composition, conditions of storage, instructions for use, supplementary labelling and, where necessary, shelf life of medicinal products entered in the list of medicinal products prepared as officinal formulae shall be published on the website of the State Agency of Medicines. The preparation of medicinal products prepared as magistral formulae shall be governed by the rules applicable to the preparation of medicinal products prepared as officinal formulae, where relevant. Medicinal products which have been prepared as officinal formulae in pharmacies and which have not been entered in the list of medicinal products prepared as officinal formulae may only be dispensed on the basis of a medical prescription or order form.

 (4) Medicinal products containing narcotic drugs and psychotropic substances may be prepared only on the basis of a medical prescription or order form.

 (5) Dividing-up from packaging and counting-out from packaging shall only be allowed, if a suitable retail packaging is not available on the market or if the suitable packaging is not the most favourable solution to the patient. The most favourable medicinal product suitable to the patient shall be used for dividing-up.

 (6) The bisection of medicinal products shall only be allowed if a score line has been provided, and on the condition that, according to the summary of product characteristics, the bisection allows to divide the doses equally and does not affect the absorption or effect of the medicinal product. Suitable working tools shall be used for the bisection, and the bisection shall be carried out immediately before the dividing-up of the medicinal product.

 (7) Sterile medicinal products may not be divided-up.

 (8) Only solid, oral pharmaceutical forms may be subjected to personal dividing-up.

 (9) A pharmacist shall assess the suitability of medicinal products for personal dividing-up, including the suitability for manual or device-assisted dividing-up in order to ensure preservation of the quality of medicinal products and prevent cross-contamination of medicinal products. The assessment of the suitability of medicinal products shall be documented.

 (10) Anticancer medicinal products, volatile pharmaceutical forms or medicinal products the characteristics of which allow to presume their unsuitability for personal dividing-up shall not be subjected to personal dividing-up. Antibacterial medicinal products for systemic use may only be divided-up manually.

 (11) Where special instructions have been given for the administration of a medicinal product subjected to personal dividing-up, the medicinal product shall be separately packaged for each round of administration.

 (12) In case of personal dividing-up of medicinal products, the medicinal products required for a period of up to two months may be divided-up and dispensed at a time.

 (13) For personal dividing-up, the provider of the pharmacy service shall enter into a written agreement with the person ordering the dividing-up service, specifying at least the following conditions for the provision of the service:
 1) the data used as basis for dispensing the medicinal products;
 2) the period for which the medicinal products are to be dispensed;
 3) the medicinal products (name of the proprietary medicinal product, pharmaceutical form, active substance and its content in the medicinal product) to be dispensed upon entry into the agreement, and the rounds of administration thereof (the medicinal products used for each round of administration, quantities, time of administration);
 4) the principles pursuant to which changes may be introduced in the data provided in clauses 1–3, including changes in the price or limit price of the medicinal product, and the format in which the changes in the dividing-up service are to be fixed;
 5) the means for ensuring availability of updated package leaflets;
 6) service fee;
 7) the procedure for dispensing medicinal products, the payment procedure and, if necessary, the settlement procedure;
 8) the terms and conditions for amendment and termination of the agreement;
 9) the patient's name and contact data;
 10) name and contact data of the patient's family physician and, if necessary, other attending physicians;
 11) names and contact data of the parties to the agreement.

 (14) The qualification, calibration, validation, checking and maintenance of the working tools and equipment used in the preparation and dividing-up of medicinal products shall be documented.

 (15) Any errors or deviations occurring in the preparation and dividing-up of medicinal products shall be documented. An overview of the errors and deviations as well as the measures taken for their correction shall be documented at least once a year.

§ 4.  Conditions for preparation and dividing-up

 (1) The preparation of non-sterile medicinal products shall take place in the auxiliary room. The preparation of sterile medicinal products shall take place in the auxiliary room of the sterilisation section. The dividing-up of medicinal products shall take place in the auxiliary room or the dividing-up room.

 (2) The washing and rinsing of pharmacy utensils, working tools and packaging shall take place in the washing room.

 (3) Non-sterile medicinal products shall be prepared and divided-up in a hygienic manner. Working clothes, headgear and, where necessary, a beard cover shall be worn. Rubber gloves shall be used for direct contact with a medicinal product or its starting materials.

 (4) Sterile clothing, headgear, foot covers and, if necessary, mask shall be worn when preparing sterile medicinal products. In addition, a sterile mask and gloves shall be worn when preparing medicinal products aseptically.

 (5) The sterile clothing shall be stored in the airlock of the sterilisation section. Working clothes shall be sterilised in an autoclave. The preparation for work (dressing, hand washing and disinfecting) shall take place in the airlock. It is forbidden to re-enter the sterilisation section and resume work after exiting the sterilisation section during work.

 (6) The substances, working tools and primary packaging used for aseptic preparation shall be sterile.

 (7) Volatile and aromatic medicinal products shall be prepared and divided-up by using local exhaust ventilation or as close to the exhaust point of the general ventilation system as possible.

 (8) Contamination and cross-contamination of medicinal products shall be avoided when preparing and dividing-up medicinal products.

 (9) Partially divided-up original packaging shall be labelled accordingly.

§ 5.  Requirements for packaging materials, pharmacy utensils and working tools used for preparing and dividing-up medicinal products

 (1) The packaging used in the preparation and dividing-up of medicinal products shall comply with the requirements established for materials and items that are allowed to come into contact with food.

 (2) The tools and equipment used in the preparation and dividing-up of medicinal products shall comply with the designated purpose of use, be qualified and calibrated, ensure prevention of errors, be easily cleanable, in working order, checked and maintained.

 (3) The measuring instruments used in the preparation and quality control of medicinal products shall be checked in accordance with the Metrology Act.

 (4) In case of device-assisted personal dividing-up, the dividing-up process and the computer system used shall be validated. The validation shall be documented. The maintenance of the computer system and storage of electronic data shall be described in the work procedure rules and ensure preservation and availability of the data.

 (5) Medicinal products shall be prepared and divided-up without any delay, so as to avoid unjustifiable storage of starting materials or medicinal products in unpackaged form. The maximum time during which a medicinal product may be used after the packaging has been opened, as provided in the summary of product characteristics, shall be taken into account when dividing-up medicinal products.

 (6) The packaging of a medicinal product shall ensure preservation of the quality of the medicinal product during the designated shelf life and on the designated conditions of storage, considering the need for repeated opening and closing of the packaging.

 (7) Glass or plastic packaging shall be used for packaging medicinal products prepared, divided-up and counted-out from packaging in a pharmacy. The primary packaging of powders divided into doses shall be moisture-proof.

 (8) The packaging of the prepared or divided-up medicinal product shall allow the user to close the packaging tightly. Photosensitive medicinal products shall be packaged in a light-tight packaging.

 (9) In case of personal dividing-up, the primary packaging of the medicinal product shall be single-use and shall prevent any mixing or mix-up of the rounds of administration.

 (10) The primary packaging of non-sterile medicinal product shall be washed and dried in hot air, where necessary. The primary packaging of sterile medicinal products shall be washed and sterilised.

 (11) The packaging used for medicinal products may be repeatedly used only after sterilisation.

 (12) Packaging, pharmacy utensils, stoppers and tools shall be washed with suitable detergents. The corresponding item shall be rinsed under running tap water at least twice, and with purified water at least twice, dried in hot air thereafter and, where necessary, sterilised. A dish washing machine may be used for washing.

 (13) Sterilisation shall be carried out for a period of 1 hour at 180 °C or 2 hours at 160 °C, if hot air is used, or for a period of 15 minutes at 121 °C, if an autoclave is used. A hot air oven shall be equipped with a suitable-scale thermometer. When using an autoclave, the temperature and pressure shall be monitored during the sterilisation process and the manometers appropriately verified. The stoppers of vials containing sterile medicinal products shall be sterilised in an autoclave for a period of 30 minutes at 121 °C.

 (14) The type and name of the sterilised material, quantity, date, conditions and time of sterilisation and the signature of the person carrying out the sterilisation shall be documented.

 (15) Washed and sterilised materials shall be stored in a locker, closed or covered. The date of the sterilisation shall be specified on the labelling of the sterilised material.

 (16) Sterilised utensils and working tools may be used for preparing sterile medicinal products for a period of 24 hours after sterilisation. Sterilised stoppers may be used for a period of 72 hours after sterilisation, if stored in a closed sterilisation container, or for a period of 24 hours after sterilisation, if stored in an open sterilisation container.

§ 6.  Shelf life of medicinal products prepared and divided-up in pharmacies

 (1) Medicinal products prepared and divided-up in pharmacies may have the following maximum shelf life, provided that the medicinal products have been prepared in accordance with the technological requirements and the requirements set forth in this Regulation and stored in appropriate conditions, and that the summary of product characteristics or the instructions specified in subsection 3 (3) of this Regulation do not foresee a shorter or longer period for storage of the medicinal product in open packaging:
 1) sterilised medicinal products and intermediate products – 30 days;
 2) aseptically prepared medicinal products – 5 days;
 3) non-sterilised aqueous solutions, emulsions and suspensions – 20 days; except for potassium iodide solution (light-tight) – 10 days; hand liquid (ammonia, glycerol, alcohol, water) – 6 months; calcium chloride hexahydrate solution and dilute hydrochloric acid – 1 year;
 4) infusions and decoctions – 5 days; except for Folium Uvae Ursi decoction – 20 days;
 5) powder divided into doses – 60 days; except for aminophylline powder in wax capsules – 20 days;
 6) quasisolid proprietary medicinal products and oil-based or glycerol-based medicinal products – 30 days; except for ichthyol ointment, nitrofural ointment (light-tight), sulfanilamide ointment (light-tight) and sulfur ointment – 1 year;
 7) alcoholic solutions – 60 days; except for boric acid solution and procaine spirit – 1 year;
 8) dilute ethyl alcohol – 90 days;
 9) medicinal products manufactured industrially and divided-up in pharmacies – 6 months.

 (2) Aseptically prepared non-sterilised medicinal products, aqueous solutions, emulsions, suspensions, quasisolid proprietary medicinal products, infusions and decoctions shall be stored at cold temperatures (2…8 °C), unless this can have an unfavourable impact on quality and unless otherwise provided in the instructions specified in subsection 3 (3) of this Regulation. Other medicinal products may be stored at room temperatures of up to 25 °C.

 (3) In case of dividing-up of medicinal products, the shelf life of a divided-up medicinal product may not exceed the expiry date established by the manufacturer. The storage conditions of the divided-up medicinal product shall comply with the conditions established by the manufacturer.

Chapter 3 Water and starting materials 

§ 7.  Preparation of purified water and water for injections

 (1) Purified water shall be used for preparing non-sterile medicinal products. Water for injections shall be used for preparing sterile medicinal products.

 (2) A pharmacy shall have access to purified water which has been either produced by the pharmacy or manufactured industrially.

 (3) Purified water and water for injections shall be prepared in the auxiliary room or washing room of the pharmacy, or in a separate room intended for the purpose.

 (4) The collection container shall be made of glass or other easily cleanable material, and closed tightly.

 (5) Purified water and water for injections shall be stored at temperatures of up to 25 °C and in such conditions as to avoid microbial contamination or microbial growth.

 (6) Purified water used for preparing medicinal products shall have a shelf life of 7 days. Water for injections shall have a shelf life of 1 day. Where the purified water has been industrially manufactured, it may be used for preparing medicinal products for a period of 7 days or 1 day after the opening of the packaging, respectively. Water used for rinsing utensils shall have a shelf life of 14 days.

 (7) Each container of purified water and water for injections shall bear the information on the date of preparation and, in applicable cases, the device used for preparing the water. The date of opening of the packaging shall be specified on the packaging of industrially manufactured water.

§ 8.  Quality and quality control of purified water and water for injections

 (1) The quality of purified water and water for injections shall comply with the requirements of the European Pharmacopoeia.

 (2) A holder of an activity licence for the pharmacy service shall check the quality of the purified water and water for injections prepared in the pharmacy, if the water is used for preparing medicinal products. Where the water quality check is not carried out by a provider of the pharmacy service, the service shall be outsourced from a person accredited to provide the corresponding service. Where the water has been prepared elsewhere, the water must be accompanied by a quality certificate containing at least the results of tests specified in subsection (3), or the quality of the water checked by the holder of an activity licence for the pharmacy service.

 (3) A minimum of three tests shall be carried out in order to check the quality of purified water: tests for chlorides, ammonia and calcium/magnesium. A minimum of five tests shall be carried out in order to check the quality of water for injections: tests for chlorides, ammonia, calcium/magnesium, reducing agents and acidity/alkalinity.

 (4) Microbiological purity tests shall be carried out at least once a year for water used for preparing non-sterile medicinal products, and at least once every six months for water use for preparing sterile medicinal products.

 (5) The water used for preparing non-sterile medicinal products in pharmacies shall be submitted for testing to the State Agency of Medicines once every six months, and the water used for preparing sterile medicinal products once a quarter.

 (6) The requirements established in subsections (2)–(5) of this section shall not be applied to industrially manufactured water.

§ 9.  Starting materials used for preparing medicinal products

 (1) At least an organoleptic identity test shall be carried out upon initial opening of the packaging of the starting material. The date, name of the starting material, name of the manufacturer, batch number, parameters (aroma, colour, etc.) and result of the identity test shall be documented.

 (2) Starting materials may be stored in the supplier's packaging, unless the supply packaging is made of plastic or paper. Starting materials packaged in plastic or paper shall, upon their initial opening, be stored in a tightly closed, clean pharmacy packaging (hereinafter storage container).

 (3) Only a single batch may be stored in a storage container. The storage container shall be washed upon depletion of the batch.

 (4) The storage container shall bear the name of the starting material batch number, shelf life, manufacturer, date of filling, signature of the person who filled the container and price per unit (e.g. gram, kilogram).

Chapter 4 Labelling of medicinal products 

§ 10.  General requirements for labelling

 (1) The data presented on the label shall be printed or written in legible handwriting. It is forbidden to use abbreviations unknown to the patient.

 (2) The labelling of a medicinal product shall not contain any corrections.

 (3) The data shall be marked or attached to the packaging in such a way that the data would be legible after the opening of the packaging and during the entire shelf life of the medicinal product.

 (4) The quantity of the medicinal product shall be specified on the packaging as follows:
 1) in case of medicinal products divided into doses, the number of units per packaging (capsules, suppositories, etc.);
 2) in case of medicinal products that have not been divided into doses, the quantity in millilitres or mass in grams (mixtures, suspensions, ointments, etc.).

 (5) The composition of the medicinal product shall be specified on the packaging as follows:
 1) the name and content of all ingredients of the medicinal product;
 2) the content of the ingredients shall be presented per dose, millilitre or gram in millligrams (1000 mg or more – in grams, less than 0.1 mg – in micrograms), millilitres, other international units of measurement (IU, mmol, etc.) or percentages. In addition, the content of the ingredients may be provided per total mass or total volume of the medicinal product.

 (6) The shelf life of the prepared or divided-up medicinal product shall be specified on the packaging in the following format: "Expiry date: day, month, year".

 (7) The packaging of a medicinal product shall contain information on the route of administration, specified as "For internal use", "For external use", "For eye treatment", "For injection", etc., specifying the route of administration where necessary. In case of medicinal products intended for injection, the route of administration may be abbreviated – inf, iv, im, sc.

 (8) Special warnings and specifications on the use and storage of the medicinal product shall, where necessary, be stated on the packaging, e.g.: "To be dissolve in water before administration", "To be mixed with water before administration", "Warning! May cause dizziness”, "To be kept at room temperatures of up to 25 °C”, "To be protected from light", "Flammable", etc.

 (9) The packaging of a veterinary medicinal product shall contain the words "For veterinary use only".

§ 11.  Labelling of medicinal products prepared as magistral formulae in general pharmacies

 (1) The packaging of a medicinal product prepared as magistral formula shall contain the following data:
 1) name of the pharmacy;
 2) name and age (in years; in case of children less than 3 years of age: in years and months) of the patient;
 3) name of the issuer of the medical prescription;
 4) number of the medical prescription;
 5) instructions for use in accordance with the medical prescription;
 6) composition of the medicinal product;
 7) pharmaceutical form;
 8) route of administration;
 9) quantity in the packaging;
 10) date of preparation;
 11) shelf life;
 12) the warning "To be kept out of reach and sight of children";
 13) special warnings and specifications, where necessary;
 14) price.

 (2) Where a medicinal product has been previously prepared as officinal formula in a pharmacy, the packaging shall also contain information which is not included in the packaging of the medicinal product prepared as officinal formula. In such cases the serial number of the medicinal product shall be specified on the medical prescription.

 (3) Where a general pharmacy dispenses medicinal products prepared as magistral formulae on the basis of an order form, the medicinal products shall be labelled in accordance with the requirements set forth in subsection 12 (1).

§ 12.  Labelling of medicinal products prepared as magistral formulae in hospital pharmacies

 (1) The packaging of a medicinal product prepared as magistral formula shall contain the following data:
 1) name of the pharmacy;
 2) name of the orderer;
 3) composition of the medicinal product;
 4) pharmaceutical form;
 5) route of administration;
 6) quantity in the packaging;
 7) date of preparation;
 8) shelf life;
 9) special warnings and specifications, where necessary;

 (2) Where a hospital pharmacy dispenses medicinal products prepared as magistral formulae on the basis of the order of a general pharmacy, the medicinal product shall be labelled in accordance with the requirements set forth in section 11.

§ 13.  Labelling of medicinal products prepared as officinal formulae

 (1) The packaging of medicinal products prepared as officinal formulae shall contain the following data:
 1) name of the pharmacy;
 2) serial number;
 3) date of preparation;
 4) shelf life;
 5) name and composition of the medicinal product in accordance with subsection 3 (3) of this Regulation;
 6) pharmaceutical form;
 7) route of administration;
 8) quantity of the medicinal product in the packaging;
 9) instructions for use in accordance with subsection 3 (3) of this Regulation;
 10) the warning "To be kept out of reach and sight of children";
 11) special warnings and specifications, where necessary;
 12) price.

 (2) The packaging of medicinal products prepared as officinal formulae in hospital pharmacies shall contain the data specified in subsection (1) of this section, except for clauses 9), 10) and 12).

§ 14.  Labelling of intermediate products

  The packaging of intermediate products shall contain at least the following data:
 1) names and quantities or concentration of ingredients;
 2) date of preparation;
 3) serial number;
 4) shelf life;
 5) price per unit (gram, kilogram, millilitre, litre).

§ 15.  Labelling of medicinal products divided-up or counted-out from packaging

 (1) The packaging of divided-up medicinal products shall contain the following data:
 1) name of the pharmacy;
 2) name of the proprietary medicinal product;
 3) active substance, if this is not evident in the name of the proprietary medicinal products, and its content in the medicinal product;
 4) pharmaceutical form;
 5) quantity in the packaging;
 6) name of the manufacturer or marketing authorisation holder;
 7) batch number;
 8) shelf life, depending on the date of the dividing-up;
 9) date of the dividing-up and, in case of dividing-up from packaging, the serial number;
 10) the warning "To be kept out of reach and sight of children";
 11) special warnings and specifications, where necessary;
 12) price.

 (2) In case of medicinal products specified in subsection 3 (3) of this Regulation, Estonian-language instructions for use shall be added to the packaging. The package leaflet shall be added in case of dividing-up of proprietary medicinal products.

 (3) The packaging of medicinal products divided-up in hospital pharmacies shall contain the data specified in subsection (1) of this section, except for clauses 10) and 12).

§ 16.  Labelling of personally divided-up medicinal products

 (1) The packaging of personally divided-up medicinal products shall contain the following data:
 1) name and telephone of the pharmacy;
 2) name and date of birth of the patient;
 3) date or week day (if the labelling provides the date on which the medicinal product is to be consumed) and time of each round of administration;
 4) name of the proprietary medicinal product, pharmaceutical form, active substance and content of the active substance per medicinal product and per round of administration;
 5) a brief description (may be attached separately) for identification of the proprietary medicinal product, if the packaging contains several proprietary medicinal products;
 6) an identification code or number, which allows to match the personally divided-up medicinal product with the packaging of the proprietary medicinal product and data on the personal dividing-up agreement, dividing-up and dispensing of the medicinal product;
 7) shelf life of the medicinal product;
 8) the warning "To be kept out of reach and sight of children";
 9) instructions "To be kept in packaging, protected from light and humidity" and, where necessary, special warnings and specifications.

 (2) The packaging for each round of administration shall include data on the patient and round of administration, except if the packaging does not allow to separate single rounds of administration.

 (3) In case of personal dividing-up, the package leaflet of the proprietary medicinal product or the website where the leaflet is made available to the patient or the e-mail address where the leaflet has been posted shall be added in accordance with the agreement specified in subsection 3 (13) of this Regulation.

Chapter 5 Documenting of preparation and dividing-up of medicinal products 

§ 17.  Documenting of preparation of medicinal products prepared as officinal formulae and intermediate products

 (1) The preparation, dividing-up and pricing of medicinal products prepared as officinal formulae shall be documented on the medicinal product preparation form or other relevant document. An example of the medicinal product preparation form has been provided in Annex 2 to this Regulation.

 (2) The documentation on preparation shall contain the following data:
 1) date of preparation;
 2) serial number;
 3) rules of preparation: name and composition of the medicinal product in accordance with subsection 3 (3) of this Regulation or the composition of one retail packaging;
 4) quantity in the packaging;
 5) number of packages prepared;
 6) starting materials used in the preparation (including active substances and other ingredients), their quantity, batch number, price per unit (e.g. 1 gram) and total cost of starting materials;
 7) technological operations (powder grinding; heating; in case of sterilisation, the sterilisation method and conditions shall be specified, along with the time of commencement and completion of the sterilisation process);
 8) quantity of medicinal products left undivided;
 9) signatures of the persons who prepared and sterilised the medicinal product.

 (3) The documentation on dividing-up shall contain the following data:
 1) quantity of the medicinal product in the packaging;
 2) number of divided-up packages;
 3) packaging type;
 4) date of dividing-up;
 5) signature of the person who carried out the dividing-up;

 (4) The documentation on pricing shall contain the following data:
 1) cost of starting materials per packaging;
 2) cost of the packaging;
 3) service fee for the preparation;
 4) sales price of the packaging; in case of intermediate products, price per unit.

 (5) When granting approval for the dispensing of a medicinal product, the person responsible shall give his or her signature and specify the date thereof.

 (6) A sample of the labelling and package leaflet shall be preserved of each series, and added to the preparation form or other relevant document.

§ 18.  Documenting of preparation of medicinal products prepared as magistral formulae

 (1) The preparation of medicinal products prepared as magistral formulae shall be documented on the back of the medical prescription or order form, check-list or other relevant document.

 (2) The following shall be documented:
 1) date of preparation of the medicinal product;
 2) the substances used in the preparation and their quantities; in case of medicinal products prepared of proprietary medicinal products, the name of the proprietary medicinal product used and the batch number;
 3) in case of sterilisation, the sterilisation method and conditions shall be specified, along with the time of commencement and completion of the sterilisation process;
 4) signatures of the persons who prepared, sterilised and granted approval for the dispensing of medicinal product, and the date.

§ 19.  Documenting of dividing-up from packaging

 (1) The preparation, dividing-up and pricing of medicinal products prepared as officinal formulae shall be documented on the medicinal product preparation form or other relevant document.

 (2) The following shall be documented:
 1) date of dividing-up;
 2) serial number;
 3) data on the divided-up medicinal product (name, pharmaceutical form, content of active substance);
 4) quantity of the medicinal product in the original packaging;
 5) price of original packaging or price per unit (e.g. 1 gram);
 6) name of the manufacturer or marketing authorisation holder;
 7) batch number;
 8) shelf life;
 9) quantity of divided-up medicinal product;
 10) quantity of divided-up medicinal product in the packaging;
 11) number of divided-up packages;
 12) type of packaging material used;
 13) pricing: cost of the medicinal product per packaging, cost of packaging and sales price;
 14) signatures of the persons who divided-up and granted approval for the dispensing of the medicinal product, and the date.

 (3) A sample of the labelling shall be preserved of each series, and added to the preparation form or other relevant document.

§ 20.  Documenting of personal dividing-up

  Personal dividing-up shall be documented in a manner which allows to track all operations, starting with the removal of the medicinal product from the original packaging, and to associate the dispensed medicinal product with the batch number and the personal dividing-up agreement. The time of the operation and the person carrying out the operation shall be documented.

Chapter 6 Quality control of prepared and divided-up medicinal products 

§ 21.  Quality control in pharmacies

 (1) A provider of the pharmacy service shall organise the checking of prepared and divided-up medicinal products. Where the check is carried out by a provider of the pharmacy service and the pharmacy has more than one employee with a pharmaceutical education, the medicinal products shall be checked by the employee who did not prepare and divide-up the medicinal products. Where the qualitative or quantitative check is not carried out by a provider of the pharmacy service, the service shall be outsourced from a person accredited to provide the corresponding service.

 (2) Each medicinal product which has been prepared and divided-up from packaging shall be checked organoleptically in terms of the following characteristics: colour, uniform composition (homogeneity), no visible additives or aroma, and, in case of children's medicinal products intended for internal use, flavour. The quantity of the medicinal product and the sealing of the packaging shall be visually examined. In case of doubt, the quantity of the medicinal product shall be checked by re-weighing or re-measuring.

 (3) Eyedrops shall be additionally chemically identified. Where there is no appropriate reaction for chemical identification, the preparation of the medicinal product shall be monitored by another pharmacist or assistant pharmacist, who shall give his or her signature thereto.

 (4) Medicinal products intended for infusion and injection shall be additionally analysed qualitatively and quantitatively.

 (5) In case of doubt, all relevant control measures shall be applied, regardless of the type of the medicinal product.

 (6) In case of personal dividing-up, the packaging of all rounds of administration shall be visually examined. The principles for correction of mistakes shall be specified in the work procedure rules.

§ 22.  Documenting of quality control in pharmacies

 (1) Quality checks shall be documented on the back of the medical prescription, in the order form, preparation form or other relevant document.

 (2) The following shall be documented:
 1) date of the check;
 2) medical prescription or serial number, if the check is not documented in the preparation form or on the back of the medical prescription or order form;
 3) in case of a physical/chemical test, the test number, if the test is not documented in the preparation form or on the back of the medical prescription or order form;
 4) tested substance or checked parameter;
 5) control method;
 6) result;
 7) assessment;
 8) signature of the person performing the check; if the check is not carried out by a provider of the pharmacy service, the name of the company and person carrying out the check.

§ 23.  Submission of medicinal products to testing

 (1) Where medicinal products are prepared in a pharmacy, at least one medicinal product prepared as officinal or magistral formula shall be submitted to the State Agency of Medicines' laboratory for testing every six months.

 (2) The labelling of the medicinal product submitted for testing shall be identical to the labelling of the dispensed medicinal products.

§ 24.  Repeal of the Regulation

  Minister of Social Affairs Regulation No 39, 4 March 2005, "Conditions and procedure for preparation, dividing-up and checking of medicinal products by pharmacies, a list of medicinal products prepared as officinal formulae by pharmacies” (RTL 2005, 30, 423) is repealed.

Urmas Kruuse
Minister of Health and Labour

Marika Priske
Secretary General

Annex 1 List of medicinal products prepared as officinal formulae

Annex 2 Medicinal product preparation form

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