Decree of the Ministry of Health and the Ministry of Agriculture No. 90 / 1999 Coll.
Decree of the Ministry of Health and the Ministry of Agriculture laying down the details of the preparation and supply of medicinal products and the detailed conditions for the operation of pharmacies and other medicinal operators
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Order
Effective from 20.05.1999
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90
DECLARATION
Ministry of Health and Ministry of Agriculture
of 9 April 1999
laying down details on the preparation and supply of medicinal products and the conditions for the operation of pharmacies and other medicinal product-issuing operators
The Ministry of Health and the Ministry of Agriculture provides, pursuant to § 75 (2) (e) of Act No. 79 / 1997 Coll., on Medicines and on amendments and additions to certain related laws, hereinafter referred to as "the Act ':
Preliminary provisions
For the purposes of this decree:
(a) individual preparation of a medicinal product according to a prescription (1) prescribed for a particular patient or animal;
(b) by mass preparation of an intermediate or final product of a medicinal product without reference to a prescription prescribed for a particular patient or animal;
(c) prepared radiopharmaceuticals prepared individually,
(d) a kit of a non-radioactive substance or a mixture of substances prepared into a pharmaceutical form to allow the incorporation of radionuclide;
(e) the activity of the preparation of radiopharmaceuticals and the amount of radioactivity in the medicinal product expressed in becquerels,
(f) a certificate of verification of the quality of the active substances and excipients;
(g) by standard operating procedure, a document setting out recurrent activities in the preparation of medicinal products;
(h) a technological prescription for a dossier which prescribes the course of preparation of the medicinal product and includes in particular the composition of the medicinal product, the determination of the packaging material, the method of labelling and the control code;
(i) a radionuclide generator of a device containing a coupled parent radionuclide providing a subsidiary radionuclide which is used as a radiopharmaceuticals or used for the preparation of radiopharmaceuticals;
(j) by triturising a mixture of a well-wiped active substance with an appropriate excipient, usually lactose, in a proportion which allows accurate weighing of the active substance.
PREPARATION AND SUPPLY OF THE MEDICINAL PRODUCTS AND BLISTERS OF THE MEDICINAL PRODUCT
PREPARATION OF MEDICINAL PRODUCTS
Principles of preparation of medicinal products
(1) For the preparation of medicinal products:
(a) active substances, excipients and plants referred to in specific legislation2) and certified by the control laboratory, (3) where appropriate, the quality of which has been verified at the pharmacy's professional workplace, 4)
(b) authorised mass-produced medicinal products; (5) for solid and semi-solid divided formulations, their possibility of use in preparation must be specified in the Summary of Product Characteristics, 6)
(c) scales allowing for the accuracy of the weighing of active substances and excipients by one order higher than the weighted amount;
(d) working items, instruments, apparatus, equipment and packaging made up of materials which do not affect the properties of medicinal products.
(2) Medicines
(a) they shall be prepared in accordance with special legislation7) or the technological regulations drawn up. For triturations into stocks containing vena, (8) narcotic drugs and psychotropic substances (9), a check on the identity and content of these substances must be carried out,
(b) must be marked in accordance with Section 5.
(3) When preparing medicinal products, no
(a) use active substances and excipients after their expiry date;
(b) prepare one worker simultaneously with several different medicinal products,
(c) weigh vena, (8) narcotic substances and psychotropic substances 9) by a person other than a pharmacist; Narcotic agents and psychotropic substances 9) may be prepared by a pharmaceutical laboratory under the supervision of a pharmacist. 10)
(4) Purified water11) may be used for the preparation of medicinal products for a maximum period of 24 hours from the time of preparation. sterilised purified water or water for injections kept in closed containers may be used for the preparation of medicinal products for a maximum period of 24 hours from the time of opening of the closure; purified water stored in a closed system for the preparation of purified water may be used for the preparation of medicinal products for a maximum period determined on the basis of process validation.
(5) Sterile medicinal products are prepared in premises with a prescribed air purity class; air purity classes are listed in the Annex.
(6) For the preparation of medicinal products of the cytostatic group, the requirements laid down for the preparation of sterile parenteral medicinal products and requirements based on the specific nature of the active substance must be complied with. 12)
(7) When preparing radiopharmaceuticals, the requirements for working with open radiolabelled lamps shall be complied with in accordance with specific legislation. 13)
(8) The preparation of medicinal products shall also be considered as
(a) consideration;
(b) filling,
(c) the distribution of individual packages of mass-produced medicinal products for sleeper medical devices.
Individual preparation
(1) Individual preparation of sterile medicinal products
(a) the parenteral material of sterile material of technology which excludes biological, microbiological, chemical or physical contamination shall be carried out in the working area of Class A, which is located in Class C,
(b) parenteral is carried out in a class C area. The requirement of sterility is ensured by heat or microbial filtration in the space of the grade A. Other sterile medicinal products without anti-microbial additives are also prepared,
(c) with an anti-microbial additive ends with membrane filtration and expansion in the purity class space Or, if the nature of the medicinal product so permits, by subsequent heat sterilisation,
(d) which cannot be heat sterilised shall be carried out in the working area of the grade A which is located in the class C space; sterile active substances and excipients shall be used to prepare them;
(e) a group of cytotoxic substances is carried out in vacuum safety boxes with a vertical laminar flow of A-grade purity and out-of-space withdrawal.
(2) If the maximum dose of the active substance is exceeded and this excess is not properly indicated by the prescribing physician as specified by the specific legislation14) and it is not possible to verify this with the prescribing physician, the pharmacist shall adjust the concentration of the prescribed active substance to the usual therapeutic dose, indicate the change on the prescription and confirm it by signature. The prescriber shall inform the pharmacist of this change.
(3) If a medicinal product prepared under a prescription does not meet the requirements of the quality, safety and efficacy of the therapeutic purpose pursued, the pharmacist shall amend the prescription, mark it and confirm it with his signature. In particular, this may be done when the prescribed medicinal product contains substances incompatible with or known to interact negatively with each other and the composition of such medicinal product with the prescribing physician cannot be consulted.
(4) If a prescription is required for a qualitative change of active substances, the pharmacist shall only do so after prior agreement with the prescribing physician. the change in the composition of the medicinal product shall be indicated on the prescription and endorsed by its signature.
(5) If the properties of the medicinal product can be improved by the use of appropriate excipients, the pharmacist may modify the composition of the medicinal product. It shall indicate the change on the prescription and confirm its signature.
Mass preparation
Mass preparation shall be carried out according to the technological regulation
(a) up to 20 packages of the final product of the medicinal product as referred to in Articles 2 and 3 and in Article 6 (1) and (2),
(b) over 20 packages of the finished product of the medicinal product, in batches, in accordance with Sections 2 and 3 and with Section 6 (3).
Labelling of active substances, excipients and medicinal products
(1) The labelling of the packages in which the active substances and the excipients are stored on the tight label, unless the packaging is labelled directly, is carried out
(a) a oblique blue stripe from the lower left to the upper right corner of the label in the case of narcotic drugs and psychotropic substances referred to in the specific legislation, 15)
(b) in white on the black label at the venages, 8)
(c) in red on the white label for separands, 16)
(d) in black, on a white label for medicines not referred to in (a) to (c);
(e) in addition to the labelling referred to in points (a) to (d), by the warning text "Flammable" for the active substances of flammable and auxiliary substances of flammable substances and "Thirsty" for the active substances of corrosive and corrosive aids.
In the absence of commercial (original) packaging, the mark shall include the certificate number or batch number.
(2) Medicinal products prepared in a pharmacy and intended for dispensing must be labelled
(a) a white label for oral use, absorption of oral mucous membranes or injection,
(b) a red label indicating "Do not use internally" if other uses are needed,
(c) if the medicinal products are intended for animals, as referred to in (a) or (b), and a green label indicating "For animals only,"
(d) with a yellow label bearing the words "Examination," if applicable,
(e) the address of the pharmacy,
(f) date of preparation,
(g) by signing the person who prepared the medicinal product, if it is prepared in accordance with Sections 3 and 4 (a),
(h) batches of the medicinal product when prepared in accordance with § 4 (b);
(i) the period of validity of the medicinal product, its storage method and instructions for use, which shall include, in particular, the method of use and the dosage of the medicinal product, if this is necessary, taking into account the nature of the medicinal product,
(j) a used antimicrobial ingredient if added during preparation. The symbol "SA 'shall be marked for eye preparations without anti-microbial additives,
(k) "Poison," if specifically stated by the physician on the prescription,
(l) by composition or, where appropriate, by name, in the case of medicinal products prepared in accordance with Article 4 or for dispensing medicinal products for medical establishments,
(m) the total quantity of the medicinal product,
(n) lots of medicinal products considered,
(o) the name, surname and date of birth of the patient and the words "Cytotoxic substance," where the medicinal products are of the cytostatic group,
(p) the name, surname and date of birth of the patient, if they are parenteral medicinal products prescribed for a particular patient,
(r) the words "Flammable" in the case of flammable medicinal products and the words "Thirsty" in the case of corrosive medicinal products.
(3) The labelling of medicinal products shall include:
(a) the name or composition;
(b) stage of preparation;
(c) the date of preparation;
(d) the signatory's signature.
Preparation control
(1) For prescription medicinal products for a particular patient or animal or prepared in bulk up to 20 packages of the final product of the medicinal product, the appearance, quantity, packaging and labelling of the medicinal product shall be checked.
(2) For medicinal products prepared in bulk up to 20 packages of the final product of the medicinal product, the certificate of the active substances and excipients used and the completeness of the dossier shall be checked, in addition to the particulars referred to in paragraph 1.
(3) For medicinal products prepared in bulk in excess of 20 packages of the final product of the medicinal product, organoleptic, chemical and physico-chemical tests shall be carried out according to the pre-prepared documentation.
(4) For medicinal products re-prepared for request1), their preparation and inspection are carried out according to a pre-established technological regulation (§ 11 (3)).
(5) For purified water a check is carried out
(a) chemical and physicochemical, namely:
1. at least once a month; and
2. after each intervention in the apparatus for its preparation,
(b) microbiological, at least twice a year, from samples taken from the apparatus and from the containers in which the prepared water is stored.
The procedure for the preparation of purified waters.7)
(6) Before the use of active substances and excipients, each pack must be verified by physical chemical and organoleptic tests.
SUPPLY OF MEDICINAL PRODUCTS
(1) For more than one medicinal product to be given to a patient on completed receptor forms (hereinafter "the recipe"), the pharmacist shall verify the dosage and method of administration indicated prior to their delivery. The pharmacist shall suspend the issue of medicinal products if, according to his knowledge and experience, he or she is likely to have an adverse effect on their application; The medicinal product shall be consulted by the doctor and, in case of unavailability, shall not issue medicinal products unless there is a risk of delay. 17) Any changes and the reason for the publication will mark the recipe.
(2) If the recipe fails
(a) the signature of the doctor;
(b) the stamp of the medical establishment, 18) if not the risk of delay;
(c) the name and surname, the insured person's identification number and, if they cannot be completed,
The pharmacist shall not issue the medicinal product.
(3) If the prescribed medicinal product is not available in the pharmacy, the pharmacist shall replace it with another medicine containing the same active substance in the same pharmaceutical form. in the event of a difference in the amount of active substance contained in the unit of mass, volume or pharmaceutical form, it shall adjust the dosage accordingly to correspond to the prescribed physician. Replacement of another medicinal product with the same active substance in another medicinal product or another medicinal product with another active substance may be performed by the pharmacist only after consultation with the prescribing physician. The pharmacist will draw the patient's attention to the substitution and mark it on the prescription, including dosage.
(4) The recipe for which the medicinal product has been issued must bear the stamp of the pharmacy at the time of issue, the date of issue and the signature of the issuing pharmacist.
(5) Medicinal products are not given in a self-service manner.
(1) When dispensing medicinal products to an order from a natural person or legal person authorised to provide health care and natural or legal persons carrying out veterinary activities (hereinafter referred to as "the applicant ') 19), that person shall confirm the receipt of the medicinal products issued on the original and the signature thereof or shall be done in writing by the authorised person.
(2) For the transport of medicinal products of the group of cytotoxic agents, only airtight means of transport may be used to protect them from deterioration or from pollution. The means of transport shall be marked with the warning "Cytotoxic substance '.
(3) Medicinal products prepared in a pharmacy containing vena or separanda, with the exception of medicinal products in which the vena or separanda is used as an anti-microbial additive, are not to be issued without a prescription.
Medicinal products containing narcotic substances and psychotropic substances
Medicinal products containing narcotic substances and psychotropic substances shall not be issued without a prescription or a prescription for one prescription. 20) If medicinal products containing narcotic substances and psychotropic substances referred to in special legislation15) are issued on demand, 21) they may only be taken over by a doctor, veterinarian or a central healthcare professional 22) specifically authorised by a natural or legal person authorised to provide healthcare. Otherwise, medicinal products containing narcotic substances and psychotropic substances shall be disposed of in accordance with § 7 and § 8 (1); this shall be without prejudice to the obligations laid down by specific legislation. 23)
BLISTER CONDITIONS OF THE OPERATIONS
Storage
(1) Medicinal products, active substances and excipients are kept at the pharmacy under the conditions laid down in specific legislation24) and in the case of mass-produced medicinal products by a decision to register them. Where storage of medicinal products is prescribed at a temperature below 15 ° C, the temperature of the thermograph, thermometers indicating maximum and minimum temperatures, temperature indicators or other instruments to document compliance with the prescribed temperature range shall be checked.
(2) Non-compliant medicinal products, which have expired, stored or prepared under conditions other than those prescribed, must be labelled and kept separately from other medicinal products in a pharmacy.
(3) At the request of marketing authorisation holders and drug distributors, the pharmacy shall provide them with information on the withdrawal of medicinal products.
(4) Narcotic substances and psychotropic substances must be stored in accordance with specific legislation. 25) The active substances and the excipients classified between the vena must be kept separately in lockable lockers. venes, narcotic substances and psychotropic substances may only be handled by persons with competence under a specific legislation; 26) other persons do not have access to these substances.
(5) Separanda should be kept in the preparation of medicinal products separately from other medicinal products.
Documentation
(1) Activities in the pharmacy associated with the intake and storage of medicinal products, active substances and excipients, the preparation of medicinal products, including their control, and the supply of medicinal products must be documented and carried out in accordance with this dossier.
(2) The documentation in the pharmacy consists of:
(a) records of:
1. acceptance of mass-produced medicinal products, including their batches, active substances, excipients and medicinal products prepared by another pharmacy,
2. the filling of active substances and excipients,
3. sterilisation of packaging and medicinal products, articles and equipment,
4. the control of the active substances and excipients received,
5. preparation and control of medicinal products prepared in bulk;
6. control of prepared purified water and water for injections,
7. prescribed checking of instruments,
8. prescribed inspection of premises with a specified air purity class;
9. Complaints of quality and of withdrawal of medicines,
10. dispensing of medicinal products to medical devices on demand;
11. the supply of the medicinal product to another pharmacy; such records shall indicate the lot of the medicinal product,
12. Non-breach of the integrity of the safety box for the preparation of medicinal products containing cytotoxic substances, the control of which shall be performed once a week,
13. The temperature of the stored medicinal products, active substances and excipients,
(b) prescriptions for fully paid medicinal products and veterinary medicinal products;
(c) technological regulations;
(d) standard operating procedures;
(e) records of narcotic drugs and psychotropic substances, 27)
(f) hygiene and sanitation rules;
(g) other documentation relating to the preparation of medicinal products and the operation of the pharmacy;
(h) recipes and applications for medicinal products containing addictive substances, 28)
(i) the stock records of the intake and supply of medicinal products by item, allowing a distinction between the pharmaceutical form, the quantity of the active substance contained in the unit of mass, volume or unit of pharmaceutical form and the package size of the medicinal product including the code of the medicinal product.
(3) The technological regulation dated and signed by the person responsible (29a) contains the procedure for the self-preparation of the medicinal product, including the quantity of the active substance in the unit of mass or volume and the procedures for carrying out the checks on the preparation and the extent of such checks, indicating the values to be achieved during those checks. The technological regulation shall be kept up to date and the changes made shall be marked in such a way that the original text, dated and signed by the responsible person, is legible. 29a) The technical regulation withdrawn from use shall indicate the expiry date and be signed by the responsible person. 29a)
(4) The documentation shall be kept for at least 5 years from the date of the last registration, except for the records referred to in paragraph 2 (i), which shall be kept for 3 years. The recipes referred to in paragraph 2 (b) shall be kept for a period of 6 months from the date of issue of the medicinal product.
PREPARATION AND SUPPLY OF RADIOFARMS AND BLIGHTER CONDITIONS OF OPERATIONS FOR THE SEPARATION OF NUCLEAR MEDICINES OF HEALTH EQUIPMENT
PREPARATION OF RADIOFARK
Principles for the preparation of radiopharmaceuticals
(1) For the preparation of radiopharmaceuticals they are used
(a) active substances and excipients referred to in specific legislation2) certified by the control laboratory, 3) active substances and excipients, where appropriate, of a quality verified at the pharmacy's professional workplace, 4)
(b) authorised mass-produced medicinal products, 5)
(c) articles of work, instruments, apparatus, equipment and packaging made up of materials which cannot affect the properties of medicinal products.
(2) Radiopharmaceuticals
(a) prepare according to:
1. special legislation, 7)
2. written instructions included in the marketing authorisation, 30)
3. standard operating procedures which must comply with the regulations for handling radioactive substances, 31)
(b) check and issue in accordance with the standard operating procedures referred to in (a) (3).
(3) In the preparation of radiopharmaceuticals,
(a) do not use active substances and excipients which have expired;
(b) it does not simultaneously prepare several different radiopharmaceuticals in one working position. 32)
Preparation procedure
Radiopharmaceuticals are preparing:
(a) by adjusting the volume activity of mass-produced radiopharmaceuticals;
(b) mixing the kit components with the radionuclide solution for injection,
(c) incubation of biological material with radionuclide solution in appropriate chemical form;
(d) the eradication of radionuclide generators in accordance with the marketing authorisation decision.
Working procedures
(1) Radiopharmaceuticals are prepared at the premises of the Air A Class listed in the Annex.
(2) Radiopharmaceuticals containing biological material are prepared at the premises of the air-purity class A listed in the Annex, at a post reserved for this purpose only.
(3) Radiopharmaceuticals are prepared to avoid confusion.
(4) When the prepared radiopharmaceuticals are being transported, they shall be treated in accordance with specific legislation. 33)
(5) Radiopharmaceuticals which have not been administered are considered as radioactive waste after their expiry date and are treated to that effect. 34)
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Regulation Information
| Citation | Decree of the Ministry of Health and the Ministry of Agriculture No. 90 / 1999 Coll., laying down details on the preparation and supply of medicinal products and closer conditions for the operation of pharmacies and other operators issuing medicinal products |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 20.05.1999 |
|---|---|
| Effective from | 20.05.1999 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
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