Decree No. 84 / 2008 Coll.
Ordonnance on good pharmacy practice, closer treatment conditions in pharmacies, medical institutions and other medicinal product-issuing operators and establishments
Valid
Order
Effective from 11.03.2008
Contents
ČÁST PRVNÍ
§ 1
§ 2
ČÁST DRUHÁ
§ 3
§ 4
§ 5
§ 6
§ 7
§ 8
§ 9
§ 10
§ 11
§ 12
§ 13
§ 13a
§ 14
§ 15
§ 17a
§ 18
§ 19
§ 20
§ 21
§ 22
ČÁST TŘETÍ
§ 23
§ 24
§ 25
§ 26
§ 27
§ 28
ČÁST ČTVRTÁ
§ 29
§ 30
ČÁST ŠESTÁ
§ 34
§ 35
§ 36
§ 37
§ 38
ČÁST SEDMÁ
§ 38a
§ 38b
§ 38c
ČÁST OSMÁ
§ 39
§ 40
§ 41
ČÁST DEVÁTÁ
§ 42
§ 43
§ 44
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84
DECLARATION
of 26 February 2008
on good pharmacy practice, closer treatment conditions in pharmacies, health care establishments and other medicinal product-issuing operators and establishments
The Ministry of Health and the Ministry of Agriculture shall determine, pursuant to § 114 (2) and to implement § 2 (2) (c), § 5 (4), § 8 (1), § 39 (3), § 77 (5) (b), § 79 (1) (c), § 79 (2) and (8) (c), § 79 (10), § 82 (1) and (3) (b), § 82 (4), § 83 (1) to (3), § 83 (5) (b), § 84 (3) and § 85 (1) of Act No 378 / 2007 Coll., on medicines and amendments to certain related laws (medicinal products):
INTRODUCTORY PROVISIONS
According to this decree, the preparation, modification, storage, reception and disposal of medicinal products in a pharmacy, nuclear medicine workplace, immunological or microbiological workplace, public health protection facilities and the treatment of medicinal products in the provision of health services and veterinary care shall be carried out.
For the purposes of this decree:
(a) individual preparation of a medicinal product for an individual patient according to the rules laid down in Section 79 of the Drug Act;
(b) by mass preparation of an intermediate product intended for further processing with the same health service provider or final product of a medicinal product, without reference to a prescription prescribed for a particular patient or animal;
(c) the radiopharmaceuticals to be prepared for a particular patient or group of patients for specific examinations;
(d) the activity of the radiopharmaceuticals being prepared and the amount of activity in the medicinal product at the given date and hour;
(e) in accordance with the standard operating procedure, a document setting out the recurrent activities;
(f) in the pharmaceutical form of a medicinal product, the technological processing of active substances and of excipients characterised by the shape, composition and physical structure, taking into account the physical structure, the pharmaceutical forms shall be broken down into solid, semi-solid and liquid pharmaceutical forms, taking into account the form being divided into pharmaceutical forms divided and divided; the detailed breakdown of the pharmaceutical forms is contained in Annex 1 to this Decree,
(g) the storage by the carrier of the medicinal product prior to its delivery by the carrier, including its storage in a self-service storage box, in accordance with Paragraph 18 (2) (b), in the event of a contractual shipment of the consignment.
CORRECT DOCTOR PRACTICE AND BLIGHTER CONDITIONS OF DOCTOR OPERATIONS
Principles of preparation of medicinal products
(1) For the preparation of medicinal products:
(a) the active substances and excipients listed in the Czech Pharmacopoeia (1) or in the list of active substances and auxiliaries (2), or the authorisation of the Ministry of Health under Section 11 (b) of the Medicines Act or the Central Veterinary Administration under Section 15 (d) of the Medicines Act, accompanied by evidence of their quality3) (hereinafter referred to as the certificate);
(b) authorised medicinal products4) in accordance with the conditions specified in the SPC;
(c) authorised medicinal products (4) for which this method of use is not indicated in the Summary of Product Characteristics only if there is no medicinal product available on the market for dosing or administration which is indicated on the prescription prescribed by the physician;
(d) weighing instruments allowing for the accuracy of the weighing of active substances and excipients by one order higher than the weighted amount;
(e) articles of work, instruments, apparatus, equipment and packaging, made up of materials which do not affect the properties of medicinal products.
(2) When preparing medicinal products
(a) all operations shall be documented in such a way that the quality preparation and evaluation process can be re-established; where the documentation is kept electronically, the data shall be backed up in a renewable manner;
(b) the active substances and the excipients may not be used after their expiry date or if they are found to have been affected by organoleptic control;
(c) shall be carried out in such a way as to avoid any possibility of substitution;
(d) one healthcare professional (5) may not prepare several different medicinal products at the same time;
(e) triturisation, which means a well-wiped mixture of the active substance with the excipient, usually lactose or active substance solution with the excipient, shall not be used in a proportion that allows the exact weighing of the active substance, if it contains venena1), narcotic substances or psychotropic substances for which the operator of the control laboratory (6) or pharmaceuticals have been inspected for the identity and content of these substances, except for stock solutions of antimicrobial additives in eye drops;
(f) instruments which may affect the quality of the finished medicinal product shall be regularly cleaned, checked, calibrated, validated or verified and followed by the manufacturer's instructions to ensure that their functional characteristics are maintained.
(3) Purified water1) may be stored at a temperature of not more than 25 ° C and used for the preparation of medicinal products for a maximum period of 24 hours after preparation; if stored at 2 to 8 ° C after preparation, it may be used for a maximum period of 72 hours. Longer applicability may be allowed if supported by stability studies. 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.
(4) Water for injections stored in airtight containers may be used for the preparation of medicinal products for a maximum period of 24 hours from the time of interruption of the packaging. However, when used as water purified and stored at 2 to 8 ° C, it may be used for a maximum period of 72 hours.
(5) Sterile medicinal products shall be prepared on premises and using instruments and equipment of the prescribed air purity class, which shall be regularly checked; air purity classes are listed in Annex 2 to this Decree.
(6) In the preparation of parenteral medicinal products of the cytostatics group, the requirements for the preparation of sterile medicinal products and requirements based on the specific nature of the active substance are respected.
(7) In the preparation of radiopharmaceuticals, the requirements for working with open radionuclide resources under another legislation7 shall be complied with.
(8) In addition to the procedures set out in Sections 5 to 7, the preparation of medicinal products shall also be:
(a) consideration and consideration;
(b) filling,
(c) the distribution of individual packages of authorised medicinal products to health service providers;
(d) an adjustment which is disproportionately demanding or dangerous, in particular an adjustment
1. radiopharmaceuticals,
2.
3. gene therapy medicinal products,
4. medicinal products intended for parenteral nutrition.
(9) The preparation of parenteral gene therapy medicinal products shall comply with the requirements for the preparation of sterile medicinal products and the requirements resulting from the specific nature of their components.
(10) In the preparation of medicinal products at increased risk for the health care professionals who prepare them, including parenteral medicinal products of the cytostatic group, radiopharmaceuticals and parenteral medicinal products for gene therapy, the requirements arising from the nature of the active substance and the conditions of protection of health at work under another legislation (41) shall be complied with.
Principles for the treatment of medicinal products
(1) Dilution of authorised medicinal products, the reconstitution or dilution of syrups, powder for injection and the addition of solution for injection into infusions shall be considered to be medicinal products if they are carried out in packages intended for this purpose or in the case of sterile medicinal products by means of sterile medical devices.
(2) Registered medicinal products may be adjusted only by procedures consistent with the Summary of Product Characteristics (8), in the case of unauthorised medicinal production9), as specified by the manufacturer, under conditions specified by the specific therapeutic programme10) or under conditions approved for the conduct of the clinical trial (11). If the use of a medicinal product is subject to § 8 (3) (b) (1) of the Medicines Act, it may be adjusted under the conditions laid down by the manufacturer in the current foreign summary of product characteristics. If the use of a medicinal product is subject to § 8 (3) (b) (2) of the Medicines Act, it may be adjusted according to the manufacturer's instructions contained in the documentation accompanying the advanced therapy medicinal product.
(3) The use of purified water and water for injections for the treatment of the medicinal product shall be treated mutatis mutandis in accordance with § 3 (3) and (4).
Preparation of sterile medicinal products
(1) Preparation of sterile medicinal products
(a) parenteral from sterile material of technology which excludes biological, microbiological, chemical or physical contamination shall be carried out in the working area of the air purity class A which is located in the air purity class C;
(b) parenteral is carried out in the air purity class C; the requirement for sterility is ensured by thermal or microbial filtration in the working area of the air purity class A; in the same way, other sterile medicinal products are prepared without anti-microbial additives;
c) with the anti-microbial additive ends with microbial filtration and expansion in the working area of the air purity class Or, if the nature of the medicinal product so permits, by subsequent heat sterilisation,
(d) which cannot be sterilised shall be carried out in the working area of the air purity class A which is located in the air purity class C; sterile active substances and excipients shall be used for their preparation;
(e) containing cytotoxic substances shall be carried out in vacuum safety boxes with vertical laminar flow of the air purity class A and towing outside the space which are located in the air purity class C and reserved for this purpose,
(f) for gene therapy is performed in vacuum safety boxes with vertical laminar flow of air purity class A reserved for this purpose and by towing outside the premises which are located in the air purity class B or C; in the case of products of hazard class 1 and risk class 2 without replication capability, time and mode separation is possible from preparations carried out in the same clean spaces; for products of a hazard class higher than 2 or with a reproductive capacity, preparation shall be provided in vacuum safety boxes with vertical laminar flow of the air purity class A and withdrawal outside the space which are located in the air purity class B area used solely for the treatment of medicinal products by gene therapy.
(2) Where the preparation of sterile medicinal products is carried out in closed automatic systems with a working area of the air purity class A, these automatic systems may be located in the air purity class D reserved for this purpose.
Individual preparation
(1) If the maximum dose of the active substance established by the Czech Pharmacopoe1 is exceeded, or the therapeutic dose, if the maximum dose is not established, and this excess is not properly indicated by the prescribing healthcare doctor or the veterinarian and this information cannot be verified by the prescribing physician concerned, the pharmacist shall adjust the amount or concentration of the prescribed active substance to the therapeutically customised1) and shall indicate this in the requirement to create a record of expenditure made in accordance with § 13 (1). The physician responsible shall immediately inform the pharmacist of the change.
(2) If a medicinal product prepared under a prescription, according to the knowledge and experience of the pharmacist, does not meet the quality, safety and efficacy requirements, in particular when the prescribed medicinal product contains substances incompatible or known to have an adverse effect on one another, the pharmacist shall modify the prescription in the light of a qualitative or quantitative change in the excipients or active substances. The pharmacist shall indicate the change made in the requirement to create a record of the expenditure carried out in accordance with Paragraph 13 (1) and shall prepare and issue the medicinal product in accordance with the change made. In the case of changes in active substances, this change shall be made in agreement with the prescribing healthcare doctor or the veterinarian.
(3) If it is possible to improve the properties of the medicinal product by using appropriate excipients, the pharmacist may modify the composition of the medicinal product. The pharmacist shall indicate the change made in the requirement to create a record of the expenditure carried out in accordance with Paragraph 13 (1) and shall prepare and issue the medicinal product in accordance with the change made.
(4) On a paper recipe, the pharmacist shall indicate the change made in accordance with paragraphs 1 to 3 and confirm it with his signature.
Mass preparation
(1) Mass preparation shall be carried out in accordance with a technological regulation, which means documentation prescribing the course of preparation and control of the medicinal product,
(a) up to 20 packages of the finished product of the medicinal product in accordance with Sections 3, 5 and 6 and with Sections 9 (1) and (2),
(b) over 20 packages of the finished product of the medicinal product, in batches provided for in Articles 3, 5 and 6 and in Article 9 (3);
(c) in excess of 20 packages of the finished product of the medicinal product, in the lots referred to in Article 3 (8) (a) and (c) with the procedure referred to in (a);
(d) drawn up for an intermediate product.
(2) Without a technological regulation, mass preparation shall be carried out in accordance with Article 2 (b), unless it is repeated.
Labelling of active substances, excipients and medicinal products
(1) The labelling of the packages in which the active substances, the excipients or the mixtures of excipients intended for the preparation of medicinal products are kept shall be carried out, unless the packaging is labelled directly, on a tight label,
(a) a sloping blue stripe from the lower left to the upper right corner of the label in the case of addictive substances listed in Annex 1 and Annex 5 to the Government Ordinance on the lists of addictive substances (12);
(b) in white on the black label at the vena,
(c) in red on a white label in the case of separands,
(d) in black on the white label in cases not covered by (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 or original packaging, the marking shall include the certificate number, the batch number and the expiry date.
(2) Prepared medicinal products for dispensing are indicated:
(a) a white label for oral medicinal products, absorption of mouth 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) the address of the pharmacy; if the medicinal product is supplied by a pharmacy other than that which prepared it, it shall also be marked with the address of the issuing pharmacy,
(e) the date of preparation and, where the shelf life is less than 48 hours, the time of preparation;
(f) the signature of the person who prepared the medicinal product if it is for preparation in accordance with Sections 6 and 7 (1) (a) and 7 (2),
(g) batches of the medicinal product when prepared in accordance with § 7 (1) (b) and (c),
(h) the period of validity of the medicinal product, which means the period during which, while respecting the prescribed storage conditions, the medicinal product retains its declared characteristics or the properties necessary for its intended use, the storage method and the instructions for use, containing in particular the method of use and the dosage of the medicinal product, if this is necessary to indicate the nature of the medicinal product,
(i) the antimicrobial ingredient used, if the prepared medicinal product contains it; for eye preparations without anti-microbial additives, the symbol "SA ',
(j) "Poison," if specifically stated by a healthcare professional or a veterinarian,
(k) by composition or, where applicable, by name, in the case of medicinal products prepared in accordance with Article 7 or intended for dispensing to health service providers or to veterinary surgeons,
(l) the total quantity of the medicinal product, except for individual preparation as provided for in Section 6;
(m) on behalf, where appropriate, of names, surnames, patient identification number; if the identification number has not been assigned, the date of birth of the patient and the words "Cytotoxic substance ', if the medicinal products are of the cytostatic group,
(n) on behalf, where appropriate, of names, surnames, patient identification number; if the identification number has not been assigned, the date of birth of the patient and the words "Gene therapy ', if it is for gene therapy medicinal products,
(o) the name, surname and identification number of the patient; if the identification number has not been assigned, the date of birth of the patient, if it is parenteral medicinal products prescribed for a particular patient,
(p) the inscription "Magnesium," in the case of flammable medicinal products (13), and the inscription "Thirsty," in the case of medicinal products (13).
Where an outer packaging is used, at least the particulars referred to in points (c), (g), (h), (j), (k), (l), (m), (n), (o) and (p) shall be marked.
(3) The labelling of medicinal products shall include:
(a) the name or composition;
(b) stage of preparation, if any;
(c) the date of preparation;
(d) the period of application;
(e) the signatory's signature.
(4) Medicinal products which are treated and are intended for dispensing to health service providers or to veterinary surgeons shall be marked with the name or composition, the particulars referred to in paragraph 2 (a) to (f), (h), (j), (l) and (p), unless such data are already on the packaging of the modified medicinal product or, where appropriate, the data identifying the patient under the prescription.
(5) When distributing individual packages of authorised medicinal products, these products shall bear the name, strength or concentration, batches and shelf life, unless such information is already on the packaging; in the case of thermolable medicinal products, the storage conditions shall also be indicated.
(6) The investigational medicinal products in the context of a clinical trial (hereinafter referred to as the investigational medicinal products) must be labelled by a label supplied by the contracting authority containing the data under Section 19 of the Ordinance on the correct clinical praxi37. In case the investigational medicinal products are prepared or modified before issue, the particulars referred to in paragraph 2 (d) to (f) and (h) shall be indicated below.
Receipt, preparation and modification check
(1) For medicinal products prepared, the issuing person checks the appearance, quantity, packaging and labelling.
(2) For medicinal products prepared in bulk up to 20 packages of the final product of the medicinal product, the person who prepared the medicinal product controls the certificate of the active substances used, the excipients or mixtures of excipients intended for the preparation of medicinal products and the completeness of the dossier.
(3) For medicinal products prepared in bulk in excess of 20 packages of the final product of the medicinal product, an entry, intermediate and exit check shall be carried out according to the pre-prepared dossier. After release of medicinal products prepared in lots, the sample of each batch shall be kept for the period of application.
(4) In the case of medicinal products re-prepared for demand, their preparation and control shall be carried out according to the technological regulation or the standard operating procedure prepared in advance for such cases in accordance with Section 22.
(5) The preparation of sterile medicinal products shall be carried out:
(a) checking the sterility of mass-produced medicinal products in batches;
(b) qualifications and at least every 12 months the validation of premises, apparatus and equipment with a specified air purity class;
(c) periodic checks on microbiological purity of premises reserved for their preparation.
(6) The check referred to in paragraph 5 (a) and (c) shall be carried out in accordance with the technology regulation referred to in Article 22 (3) or the standard operating procedure developed in advance for this purpose.
(7) For prepared purified water a check is carried out
(a) chemical and physicochemical, namely:
1. at least once every 2 months or at least every 6 months, if the water conductivity is measured at least once a day and the purified water preparation apparatus is equipped with a conductivity gauge which is continuously controlled; and
2. after each intervention in the apparatus for its preparation,
(b) microbiological;
1. at least once every 2 months; and
2. after each intervention in the apparatus for its preparation.
When checking purified water, follow Czech Pharmacopoeia 1).
(8) An organoleptic test shall be performed on each package prior to the use of active substances, excipients or mixtures of excipients intended for the preparation of medicinal products.
(9) After adjusting the medicinal products, the checks referred to in paragraph 1 shall be carried out.
Medicinal products
(1) Registered medicinal products are issued in accordance with the Marketing Authorisation Decision (14), in particular the Summary of Product Characteristics. The issue shall include the provision of information necessary for the correct and safe use of the medicinal products to be delivered and for their storage.
(2) Information on suspected serious or unexpected adverse events and other serious health-related effects of medicinal products for human use and defects in the quality of medicinal products for human use are collected and processed at the pharmacy and shall be notified immediately to the Institute. In the case of veterinary medicinal products, information and other relevant information for the health of treated animals shall be collected and processed mutatis mutandis and that information shall be notified without delay to the Institute for State Control of Veterinary Bioprafts and Medicines.
(3) In the case of medicinal products issued to a patient on the prescription, the pharmacist shall verify the dosage and method of administration indicated before dispensing; by the window,
(a) it may suspend the issue of medicinal products if, according to its knowledge and experience, it is likely that the medicinal products used may be adversely affected or the patient's health affected by their application; it shall consult the prescribing doctor or veterinarian and, in the event of non-attainability of the medicinal product, shall not issue medicinal products unless there is a risk of delay, state the reason for the change or omission in the request for a record of the issue made in accordance with Paragraph 13 (1) and, in the case of a prescription in paper form, indicate the reason on the prescription and confirm it by signature,
(b) issue on a paper-based recipe the number of packages of the medicinal product expressed verbally if there is a discrepancy in the recipe between the number of packages expressed in number and the word indication,
c) Consults with prescribing physician
1. the issue of a prescribed medicinal product, the payment of which by public health insurance under the Public Health Insurance Act is subject to approval by the medical examiner of the relevant health insurance undertaking and for which the recipe does not specify the amount of the approved remuneration,
2. dosing in case the dosage is exceeded according to the Summary of Product Characteristics or according to the Czech Pharmacopoeia and this is not indicated on the recipe,
(d) if no excess dosage is indicated and the prescribing physician is unattainable, in the case referred to in point (c), he shall adjust the dosage according to the Summary of Product Characteristics or the data provided in the Czech Pharmacopoeia and inform the prescriber as soon as possible;
(e) more than one package of one type of prescribed medicinal product covered by public health insurance under the Public Health Insurance Act shall issue a number of packages corresponding to the provision of patient treatment for a period of three months if the prescribed number of packages exceeds that limit.
(4) If a medicinal product is prescribed by an international non-proprietary name recommended by the World Health Organisation, indicating the required pharmaceutical form, strength and quantity of the required pharmaceutical form, the pharmacist shall issue the corresponding medicinal product with the lowest supplement for the patient. With the consent of the patient, the pharmacist may issue a medicinal product whose supplement is not the lowest. If no medicinal product is available in the pharmacy with the required amount of pharmaceutical form, the pharmacist will issue the medicinal product at the nearest pack size, taking into account the expected duration of therapy.
(5) The pharmacist does not issue the prescribed medicinal product if it is missing from the prescription in paper form.
(a) the signature of the prescriber,
(b) identification of the health service provider to which the prescription has been issued, if it is not possible to complete it and there is no risk of delay;
(c) the signature of the veterinarian and the identification of the person authorised to provide veterinary care when the medicinal product intended for the animal is delivered;
(d) the name and, where applicable, the patient's name and surname and may not be supplemented unless it is a prescription for a medicinal product in the event of a risk of delay in the provision of medical care to a patient who is at risk of death or appears to have serious health disorders;
(e) the patient's identification number and the health insurance code; if the identification number has not been assigned, the date of birth of the patient and cannot be supplemented; or
(f) the name and surname of the breeder where the medicinal product intended for the animal is delivered and cannot be supplemented.
(1) If the prescribing physician does not indicate that he insists on the issue of the prescribed medicinal product, the pharmacist may replace the prescribed medicinal product, except for investigational medicinal products, where:
(a) the patient agrees to this procedure and the medicinal product is identical in terms of efficacy and safety; and
(b) the medicinal product contains the same active substance, the same route of administration and the same pharmaceutical form; if the medicinal product contains different amounts of the active substance in the unit of mass, volume or pharmaceutical form, the pharmacist shall adjust the dosage to correspond to that prescribed by the physician.
(2) Replace the prescribed medicinal product for which the physician has indicated that he insists on the issue of the prescribed medicinal product, except for investigational medicinal products, under the conditions laid down in paragraph 1, a pharmacist may only:
(a) does not have the medicinal product prescribed by the doctor, and
(b) immediate release is necessary.
(3) Replace the prescribed medicinal product with another medicinal product with the same active substance, with the same route of administration, but in another pharmaceutical form, or with another medicinal product with another medicinal product corresponding to the therapeutic properties, including in another pharmaceutical form, except the investigational medicinal products, a pharmacist may only:
(a) the medicinal product prescribed by the doctor is not available and it is not possible to follow paragraph 1 or 2;
(b) immediate extradition is necessary; and
(c) the patient agrees to the replacement and the prescribing physician has given prior consent to the replacement in an electronic recipe note or to express consent at the time of issue;
if the medicinal product contains different amounts of the active substance in the unit of mass, volume or pharmaceutical form, the pharmacist shall adjust the dosage to correspond to that prescribed by the physician.
(4) Where a pharmacist progresses in accordance with paragraphs 1 to 3, he shall mark the paper recipe and, in the case of an electronic recipe, shall indicate in the requirement to create a record of the issue, the medicinal product issued, including any changes in payment and dosage.
(5) The dispensation of the medicinal product prescribed by the veterinarian shall be treated mutatis mutandis in accordance with paragraphs 1 to 4.
(1) The paper-based recipe and the extract from the paper-based recipe should be provided when dispensing:
(a) identification of the pharmacy;
(b) the date of issue of the prescribed medicinal product,
(c) the signature of the issuing pharmacist.
(2) When dispensing medicinal products without a prescription with a restriction of 17), the pharmacist shall verify that the conditions for restriction laid down in the marketing authorisation are met, verify the identity of the person requesting the supply of the medicinal product and provide such person with the information necessary for the safe use of the medicinal product.
(3) Medicinal products which are not restricted in accordance with Article 39 (5) of the Law on Medicines or are not subject to medical prescription may also be issued in a self-service manner at the premises of the pharmacy provided for that purpose, as well as by mail.
Issue records
(1) When dispensing a medicinal product on the basis of an electronic prescription, the pharmacist shall make a request for a record of the medicinal product that contains:
(a) the identifier of the electronic recipe on which the medicinal product is to be issued;
(b) the code of the medicinal product to be issued allocated by the Institute if it has been assigned;
(c) the quantity of medicinal product delivered,
(d) the date of issue;
(e) identification of the issuing pharmacist and identification of the pharmacy where the dispensation was made;
(f) the recognised electronic signature of the issuing pharmacist.
(2) The requirement to create an output record is sent through the information system of the issuing pharmacist to the eRecept system in accordance with the procedures and conditions for communication with eRecept, which provides for another legislation38).
(3) The eRecept system will send a confirmation of receipt and processing of the request and storage of the output record to the information system of the issuing pharmacist. This certificate shall include information on the pairing of an electronic recipe with a record of the dispensation and prescribed medicinal products actually issued.
(4) For the purpose of carrying out a record of the issue, the electronic recipe shall also mean an electronic prescription issued in another Member State on the basis of which the delivery of the prescribed medicinal product is made under Section 83b of the Drug Act.
How to convert the recipe data in paper form into electronic form
(1) When dispensing a medicinal product on the basis of a prescription issued in paper form, the issuing pharmacist shall transfer the data referred to in Section 81g (6) of the Medicines Act to an electronic form in the form of an electronic record sent to the eRecept system.
(2) If the operational reasons on the part of the issuing pharmacist do not allow the electronic record to be sent to the eRecept system immediately on the delivery of the medicinal product, the pharmacist shall send the electronic record no later than the end of the working day following the day on which the medicinal product was delivered.
(3) If the eRecept does not allow the eRecept to send an electronic record to the eRecept system for operational reasons, the pharmacist shall send an electronic record no later than the end of the working day following the day on which the full availability of eRecept is restored.
(4) The electronic record referred to in Section 81g (6) of the Medicines Act is made by means of the information system of the issuing pharmacist. Paragraph 13 (2) and (3) shall apply mutatis mutandis to communication with eRecept when sending an electronic alert.
Contents
ČÁST PRVNÍ
§ 1
§ 2
ČÁST DRUHÁ
§ 3
§ 4
§ 5
§ 6
§ 7
§ 8
§ 9
§ 10
§ 11
§ 12
§ 13
§ 13a
§ 14
§ 15
§ 17a
§ 18
§ 19
§ 20
§ 21
§ 22
ČÁST TŘETÍ
§ 23
§ 24
§ 25
§ 26
§ 27
§ 28
ČÁST ČTVRTÁ
§ 29
§ 30
ČÁST ŠESTÁ
§ 34
§ 35
§ 36
§ 37
§ 38
ČÁST SEDMÁ
§ 38a
§ 38b
§ 38c
ČÁST OSMÁ
§ 39
§ 40
§ 41
ČÁST DEVÁTÁ
§ 42
§ 43
§ 44
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Regulation Information
| Citation | Decree No. 84 / 2008 Coll., on the correct practice of pharmaceuticals, closer treatment conditions in pharmacies, medical devices and other operators and devices issuing medicinal products |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 11.03.2008 |
|---|---|
| Effective from | 11.03.2008 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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