Decree No. 254 / 2013 Coll.
Decree amending 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
Valid
Order
Effective from 01.09.2013
Text versions:
01.09.2013
19.08.2013
254
DECLARATION
of 13 August 2013
amending Decree No. 84 / 2008 Coll., on the correct practice of pharmaceuticals, closer treatment conditions for medicinal products in pharmacies, medical devices and other operators and devices issuing medicinal products
The Ministry of Health and the Ministry of Agriculture, pursuant to § 114 (2) of Act No. 378 / 2007 Coll., on Medicines and on Changes to Certain Related Acts (Act on Medicines), as amended by Act No. 50 / 2013 Coll. and Act No. 70 / 2013 Coll., for the implementation of § 5 (4), § 8 (1), § 39 (5), § 79 (2) and (8) (a) and (c), § 79 (10), § 82 (1) and (3), § 82 (4), § 83 (2) and (3), § 83 (5) and § 85 (1) of the Law on Medicines:
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, is amended as follows:
1. in Sections 1, 37 (1), 37 (2) (a) (2) and 37 (2) (c) (3), the words "health care" are replaced by the words "health services."
2. In Article 2 (b), the words "in the same health establishment 'are replaced by the words" for the same health service provider'.
3. In Article 2, at the end of point (e), the dot is replaced by a comma and the following point (f) is added:
"(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 shape of the pharmaceutical forms divided and divided; the detailed breakdown of the pharmaceutical forms is contained in Annex 1 to this Decree. ';
4. in Article 3 (1) (b):
"(b) authorised medicinal products (4) for which this method of use is not specified in the approved summary of product characteristics only if there is no medicinal product available on the market for the dosage indicated on the prescription prescribed by the physician."
5. in Articles 3 (8) (c), 8 (2) (k) and 8 (4), the words "medical establishments" are replaced by the words "health service providers."
6. In Paragraph 4, the following sentence is added at the end of paragraph 2: "If the use of a medicinal product is subject to § 8 (3) (b) (1) of the Drug Act, it may be adjusted under the conditions laid down by the manufacturer in the current foreign summary of product characteristics. Where 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. '
7. In Article 6 (1), the words "maximum" and the words "therapeutic dose, if the maximum dose is not fixed, shall be inserted after the words" maximum "and the words" or therapeutic dose "shall be inserted after the word" exceeded. "
8. in § 8 (2) (d):
"(d) the address of the pharmacy; where 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, '.
(9) Footnote 13:
"13) Act No. 350 / 2011 Coll., on Chemicals and Chemical Mixtures and on the amendment of certain laws (Chemical Act). '.
10. In Section 8, the following paragraph 7 is added:
"(7) The investigational medicinal products in the context of a clinical trial (hereinafter referred to as the investigational medicinal products) must be marked 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.
37) Decree No. 226 / 2008 Coll., on Good Clinical Practice and Closer Conditions of the Clinical Evaluation of Medicines. '.
11. in Paragraph 10 (2), "related" is replaced by "related."
12. In Paragraph 10, the following paragraph 4 is inserted after paragraph 3:
"(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, the pharmacist shall issue the appropriate 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."
Paragraph 4 shall become paragraph 5.
13. in Article 10 (5) (b), the words "a medical establishment" shall be replaced by the words "a health service provider by which."
14. Paragraph 11 (1) to (3) reads as follows:
"(1) If the prescribed medicinal product is not available in the pharmacy and its immediate issue is necessary in view of the patient 's medical condition, the pharmacist may issue a medicinal product other than the prescribed medicinal product if:
(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 with the same route of administration and in the same pharmaceutical form; This does not apply to investigational medicinal products; 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) If the prescribing physician does not indicate that he insists on the issue of the prescribed medicinal product, the pharmacist may, subject to the conditions laid down in paragraph 1 (a) and (b), issue a medicinal product other than the prescribed medicinal product.
(3) Where a pharmacist is referred to in paragraph 1 or 2, he shall indicate on the prescription the medicinal product issued, including any changes in payment and dosage. ';
15. in Article 11 (5), the word "replacement" shall be deleted, the words "for a medicinal product prescribed" shall be replaced by the words "prescribed" and the words "mutatis mutandis" shall be added at the end of the text of the paragraph.
16. In Article 12 (2), the word "him" is replaced by "such a person."
17. in Article 12 (6), the words "is not limited in accordance with Article 39 (5) of the Law on Medicines or" shall be inserted after the word "supply."
18. Paragraph 12 (7), including footnote 20, is deleted.
19. in Article 17 (5) (a), "DTD" is replaced by "XSD."
20. After Article 17, the following paragraphs 17a and 17b are inserted:
Record in the restricted medicinal product register
(1) If a restricted medicinal product is to be issued, the pharmacist shall verify that the conditions for the preparation or supply of such medicinal product are met.
(2) Verification of the possibility of preparing or dispensing a prescription medicinal product with a restriction or a cannabis-containing medicinal product for therapeutic use shall be carried out by the pharmacist through his information system in the restricted medicinal product register by indicating the identification mark of the electronic recipe with the prescribed medicinal product. In the case of a medicinal product without a prescription, it shall indicate the insured person's identification number and, if not the insured person, the name, surname and date of birth of the natural person.
(3) A pharmacist for access to a restricted register of medicinal products uses the same access data as for communication with the central repository of electronic recipes. Paragraph 13 to 16 shall apply mutatis mutandis to the restricted register. Through the restricted medicinal product register, the pharmacist shall be informed whether the conditions for the preparation or supply of the restricted medicinal product are met.
(4) If the conditions for the preparation of a medicinal product containing cannabis for therapeutic use are met, the pharmacist shall record the preparation in the medicinal product register, which shall include:
(a) the type of cannabis prescribed for therapeutic use and its code under the legislation governing the conditions for prescription, issue and use of cannabis for therapeutic use;
(b) the amount of hemp for therapeutic use in the preparation of the medicinal product,
(c) the start date of preparation; and
(d) identification of the preparing pharmacist and identification of the pharmacy where the preparation is made.
(5) If the conditions for the supply of a medicinal product subject to a restricted or non-restricted prescription are met, the pharmacist shall record the supply in the restricted register in accordance with the procedure laid down in Section 13.
Communication of pharmacist with the restricted medicinal product registry and technical documentation
(1) The pharmacist communicates with the restricted medicinal product register via the software communication adapter. Electronic communication between the pharmacist and the restricted medicinal product register takes place in a secure manner,
(a) all data sent to the restricted medicinal product register shall be signed by a recognised electronic signature;
(b) all data received from the restricted medicinal product register shall be signed by a recognised electronic signature; and
(c) the transmitted data or communication channel is encrypted.
(2) Any access by a pharmacist to the restricted medicinal product register shall be subject to the verification by the registry of its access authorisation.
(3) The communication of the pharmacist with the restricted medicinal product register, including any data transmission related to the issue, takes place in the labelling language format. It is always confirmed through the restricted medicinal product register to the receiving and storage of data.
(4) All communications and data transmitted between the pharmacist and the restricted medicinal product register are recorded in the records of the entries and activities of the restricted medicinal product register. This register contains:
(a) acceptance of the request, including the data sent, identification of the sending pharmacist, date and time of receipt of the request and, where appropriate, other necessary information relating to the receipt of the request;
(b) the dispatch of data from the restricted medicinal product register, the data sent, the date and time of dispatch of the data and, where appropriate, other necessary information related to the dispatch of the data; and
(c) acceptance of the report of the issuing pharmacist on the delivery including the data sent, in the case of preparation of a medicinal product containing cannabis for the therapeutic use of the report of the pharmacist initiating the preparation, identification of the sending pharmacist, date and time of receipt of the report and, where appropriate, other necessary information relating to the receipt of the report.
(5) The technical documentation relating to the supply of medicinal products with restrictions and communication with the restricted medicinal product register shall be published in electronic form by the Institute in a way which allows remote access and contains:
(a) specification of the format of the marking language of the interface of all necessary documents, including definition schemes for the validation of documents in the standard extendable language - XSD and documents for the validation of the marking language format;
(b) a detailed description of the communication with the restricted medicinal product register and the communication adaptor; and
(c) the specification of the security of access and data transferred between the pharmacist information system and the restricted medicinal product register and other necessary specifications. ';
21. In Paragraph 18 (3), the words "or the Institute for State Control of Veterinary Bioprafts and Drugs" shall be inserted after the words "State Institute for Drug Control."
22. in Paragraph 19 (1), the words "Medical facilities" are replaced by the words "Health service provider."
23. in Articles 19 (4), 22 (2) (a) (10) and 33 (1) (b), the words "medical establishments" are replaced by the words "health service providers."
24. In Article 21, the following paragraph 5 is added:
"(5) The investigational medicinal products shall be kept under conditions specified by the manufacturer or the sponsor of the clinical trial; must be kept separate from other medicinal products in such a way as to distinguish medicinal products from each clinical trial. '
25. In Article 22 (2) (a) (1), the words "and the codes assigned by the State Institute for the Control of Medicinal Products or the Institute for the State Control of Veterinary Bioprafts and Drugs" shall be inserted after the words "their lot" and the words "at the end of the text of the point" shall be added. "
26. in § 22 (2) (a) (12):
'12. the supply of the authorised medicinal product to another pharmacy under the conditions laid down in Section 82 (4) of the Drug Act; such records shall contain an indication of the batch of the medicinal product and the code assigned by the State Institute for Drug Control or the Institute for State Control of Veterinary Bioprafts and Drugs, '.
27. in Article 22 (2), the words "or the Institute for State Control of Veterinary Bioprafts and Drugs" shall be added at the end of the text in point (k).
28. In Paragraph 22, at the end of paragraph 2, the dot is replaced by a comma and the following point (m) is added:
"(m) records related to the exchange of withdrawn medicinal products to identify the medicinal product exchanged, indicating its code assigned by the State Institute for Drug Control or the Institute for State Control of Veterinary Bioprafts and Drugs and batch numbers; the register shall also include a brief record of the reason for the withdrawal, the date of the exchange and the record of the surrender of withdrawn medicinal products pursuant to Article 89 (1) or (3) of the Drug Act. ';
29. In Article 22, the following paragraph 5 is added:
"(5) The documentation on investigational medicinal products at the pharmacy shall consist of records of the admission and disposal of investigational medicinal products, including records of the storage conditions of investigational medicinal products. ';
30. In the heading of Part Three, the words "HEALTH EQUIPMENT 'are deleted.
31. in Article 23 (2) (a):
"(a) prepare according to technological regulations or standard operational procedures, taking into account regulations for the handling of radioactive substances (7), (27), and
1. Czech Pharmacopoeia,
2. summaries of product characteristics and package leaflet for authorised medicinal products; or
3. the procedure approved in the framework of the clinical trial, '.
32. in Article 23 (2) (b), the words "point 3" shall be deleted;
33.In Article 33 (1) (c), the words "health establishments" are replaced by the words "health service providers."
34. In the heading of Part Six, the words "HEALTH HEALTH 'are replaced by the words" HEALTH SERVICES WITH EXCEPTION OF HEALTH'.
35.
Supply of medicinal products
The health service provider shall be supplied by the pharmacy or by the operator of another workplace or establishment preparing the medicinal products. Transfusion products shall supply transfusion services to providers of health services; gases used in the provision of health services, advanced therapy medicinal products, investigational medicinal products, infusion products, hemofiltration and dialysis solutions and immunological products for vaccination may also be supplied by distributors of medicinal products. The health service provider shall proceed with the treatment of medicinal products to ensure the quality, efficacy and safety of the medicinal products used.
Treatment of medicinal products
The modification of medicinal products by the health service provider shall be carried out according to the summaries of the particulars of the individual medicinal products, the manufacturer's or clinical trial sponsor's instructions or standard operating procedures in which the conditions of preparation referred to in Sections 3 (4) and (8), 4 (1), 8 (4) and 9 (7) apply. ';
36. In Article 36, the following paragraph 4 is added:
"(4) The investigational medicinal products shall be kept separately from other medicinal products, as instructed by the manufacturer or the clinical trial sponsor. ';
Efficacy
This Decree shall take effect on 1 September 2013.
Minister for Health:
MUDr. Holcat, MBA, Rev.
Minister for Agriculture:
Toman v. r.
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Regulation Information
| Citation | Decree No. 254 / 2013 Coll., amending Decree No. 84 / 2008 Coll., on Good Drug Practice, Closer Treatment Conditions in Pharmacy, Medical Devices and Other Operators and Medicinal Products Issuers |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 19.08.2013 |
|---|---|
| Effective from | 01.09.2013 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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