Decree No. 252 / 2018 Coll.
Decree amending Decree No. 229 / 2008 Coll., on the Production and Distribution of Drugs
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Effective from 01.01.2019
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252
DECLARATION
of 26 October 2018
amending Decree No. 229 / 2008 Coll., on the Production and Distribution of Medicines
The Ministry of Health and the Ministry of Agriculture, pursuant to § 114 (1) and (2) of Act No. 378 / 2007 Coll., on medicinal products and on amendments to certain related laws (Act on Medicines), as amended by Act No. 50 / 2013 Coll., Act No. 70 / 2013 Coll. and Act No. 66 / 2017 Coll., to implement § 63 (1) and (6), § 64 (j), § 69 (2), § 70 (1), § 71 (2) and (6), § 72 (1), § 73 (9) (b), § 74 (1) and (5), § 75 (2), § 77 (1) (e) to (i) and (q), § 77 (3) and § 77 (5) (a) of the Law on medicinal products:
Decree No. 229 / 2008 Coll., on the production and distribution of medicinal products, is amended as follows:
1. In Section 1 of the introductory part of the provision, the words "European Community1) 'are replaced by the words" European Union1)'.
2. In Paragraph 4, the word "Community 'is replaced by the words" European Union' and the words "Community 'are replaced by the words" European Union'.
3. in Articles 5 (1) and 18 (1) and (2), "in the Community" shall be replaced by "in the European Union."
4. In the last sentence of Paragraph 9 (1), "(d) 'is replaced by" (c)'.
5. In Paragraph 10 (1), the comma at the end of point (c) is replaced by a dot and point (d) is deleted.
6. in Articles 11 (6) and (7), 16 (1), 31 (1) (a), 31 (3), 33 (1), 40 (5) and (6) and 46, the word "Community" shall be replaced by the words "European Union."
7. In Paragraph 12 (1), the second sentence is deleted.
8. In Article 17, the word "Community 'is replaced by the words" European Union'.
9.
(1) The provisions of this Regulation shall apply mutatis mutandis to the operation of the control laboratory.
(a) Articles 3, 4, 6 to 9 and 11 to 14, if it is for medicinal products for human use or active substances and excipients for the manufacture of medicinal products for human use; or
(b) Articles 16 to 22 and 24 to 27, if it concerns veterinary medicinal products or active substances and excipients for the manufacture of veterinary medicinal products.
(2) The control laboratory shall issue proof of the quality of the active substance or of the excipients supplied to persons authorised to prepare medicinal products. "
10. In the title of Part Seven, the words "AND EXCIPIENTS 'are deleted.
11.
(1) Unless otherwise provided for in this Part, the provisions on good manufacturing practice set out in Part Three shall apply mutatis mutandis in the manufacture and control of active substances for the manufacture of veterinary medicinal products.
(2) Compliance with the conditions of good manufacturing practice in the manufacture of active substances by a manufacturer of active substances is demonstrated by a certificate of good manufacturing practice for manufacturers of active substances issued in accordance with European Union procedures for the inspection and exchange of information2). Paragraph 43 shall apply mutatis mutandis to the details of the application for the issue of a certificate for the manufacturer of active substances and to the changes to the data in that application. In the case of a certificate of good manufacturing practice for manufacturers of active substances issued by the Veterinary Institute, the certificate shall indicate the individual active substance. ';
12. in Paragraph 35 (a), "39" is replaced by "40."
13. in Paragraph 35 (b), the words "or medicinal products for human use intended for specific therapeutic programmes7) shall be replaced by the words" medicinal products for human use intended for specific therapeutic programmes7), medicinal products for which a hospital exemption has been authorised, investigational medicinal products, "
14. in Paragraph 35, point (e) is deleted;
15. The following Sections 35a to 35d are inserted after Section 35, including the headings and footnotes 11, 13 and 14:
Supplies of medicinal products for human use
The distributor shall check before the distribution of each batch of authorised medicinal products manufactured in a Member State of the European Union that the certificate of release of that batch of medicinal product signed by a qualified person of its production13 has been issued.
Provision of data on the volume of medicinal products distributed
(1) The distributor shall provide the Institute with the data referred to in Section 77 (1) (f) of the Drug Act by electronic notification in the previous calendar month, no later than the 10th day of the following calendar month. For the purposes of this Decree, the manufacturer is also considered to be a distributor under Section 75 (5) of the Drug Act.
(2) The distributor shall provide the report referred to in paragraph 1 through the communication interface of the Institute through its information system, which allows the exchange of messages in a generally accepted data format according to the technical documentation published by the Institute. Access data and the unique identifier of the distributor shall be allocated by the Institute to the distributor on request for each approved storage area separately. The communication interface is created in the form of a web application interface and is published by the Institute through the Institute's website, including its technical documentation. For the purposes of technical assistance and unifying procedures, the Institute shall publish the recommended procedures for the submission of correct and complete reports in a manner that allows remote access.
(3) An update of the report already provided pursuant to paragraph 1 may be made by the distributor between the 10th and 20th day of the calendar month. After the 20th day of the month, the content of the report cannot be changed. Where a distributor finds, after the 20th day in a calendar month, that he has entered incomplete or incorrect information in the report, he shall immediately send the Institute a corrective report.
(4) The report referred to in paragraph 1 and, where appropriate, the corrective report referred to in paragraph 3 shall contain:
(a) the distributor identification code assigned by the Institute;
(b) the calendar month and year for which the report is sent;
(c) the unique message identifier assigned by the Institute;
(d) an identifier indicating the delivery of medicinal products or advertising samples;
(e) identification of the person to whom the medicinal product has been supplied, in accordance with Section 77 (1) (c) of the Medicines Act, including whether it is a customer in the Czech Republic or outside the Czech Republic,
(f) identification of the medicinal product,
1. the code of the medicinal product allocated by the Institute; if the medicinal product does not have a code, the name of the medicinal product, its batches, in the case of non-authorised medicinal products, by the composition and package size,
2. the price of the originator for which the medicinal product was placed on the market (11), and
3. determining whether it is a registered medicinal product with a code allocated by the Institute distributed in the Czech Republic, including advertising samples of such medicinal products, or whether it is an unregistered medicinal product with a code allocated by the Institute distributed in the Czech Republic under an approved specific treatment programme, or whether it is an unregistered medicinal product not assigned by the Institute to a code supplied by a distributor to individual patients in the Czech Republic in accordance with § 8 (3) to (5) of the Law on Medicines, or whether it is an unregistered medicinal product not assigned by the Institute to a code supplied by distributors to an authorised customer in the Czech Republic (14); and
(g) the number of packages of the medicinal product.
(1) The distributor shall send to the Veterinary Institute the report referred to in Article 77 (1) (f) of the Drug Act in the past quarter, no later than the 30th day of the following calendar month. The distributor shall send reports in accordance with the instructions of the Veterinary Institute published via the Veterinary Institute's website.
(2) The report referred to in paragraph 1 shall contain:
(a) the identification of the distributor by the name, surname, place of business and identification number, if assigned, if any; in the case of a legal person, the name or business name, address of the registered office and identification number shall be indicated;
(b) identification of the quarter for which the report is sent;
(c) the identification of the distributed medicinal product by the veterinary medicinal product code assigned by the Veterinary Institute and the name of the veterinary medicinal product; in the case of non-authorised veterinary medicinal products, where the veterinary medicinal product does not have a code assigned, the name of the veterinary medicinal product, its batches and the packaging size,
(d) identification of the person to whom the veterinary medicinal product has been distributed, distinguishing between:
1. the veterinarian,
2. pharmacy,
3. seller of reserved veterinary medicinal products,
4. another distributor,
5. the manufacturer of medicated feed; or
6. breeders; and
(e) the number of packages of the medicinal product.
(3) Where the distributor subsequently finds that he has entered incomplete or incorrect information in the report, he shall immediately send an corrective report to the Veterinary Institute.
(4) In case medicinal products not intended for marketing in the Czech Republic are distributed via distribution warehouses in the Czech Republic, these deliveries are reported in the part of the report for unregistered medicinal products without the codes assigned by the Veterinary Institute.
Distribution of a medicinal product outside the Czech Republic pursuant to § 77 (1) (q) of the Drug Act is notified electronically. In this case, the medicinal product is identified by the registered name of the medicinal product, the additional name, the code assigned by the Institute and the number of packages.
11) Price regulation of the Ministry of Health on regulating the prices of medicinal products and foodstuffs for special medical purposes.
13) Paragraph 77 (7) (g) of Act No. 378 / 2007 Coll.
14) § 77 (7) (c) of Act No. 378 / 2007 Coll. '.
16. in Article 36 (1), the words "In order to ensure the storage and handling of medicinal products, the distributor shall provide sufficient numbers at each distribution point for the activities carried out" shall be replaced by the words "The distributor shall provide sufficient numbers in each authorised storage area for their distribution."
17. in Paragraph 36 (2):
"(2) Distributor in relation to workers involved in the distribution of medicinal products
(a) lay down in writing the tasks and powers of the staff involved in the distribution activities and the provision of a quality assurance system, including their interchangeability;
(b) ensure sufficient powers, material equipment and operational technical conditions for the performance of the duties of a qualified person under Section 76 (1) (b) of the Drug Act; a qualified person shall perform his duties in person and be responsible for their performance; and
(c) ensure that all employees active in the field of distribution are regularly trained at the start of the activity and then regularly trained on the requirements of good distribution practice according to the scope of the activities performed, including persons performing distribution activities under contract. ";
18. In Paragraph 36, paragraphs 3 and 4 are added:
"(3) In the case of medicinal products for human use, a qualified person may only be appointed for the performance of his or her activities within the scope of the authorisation to distribute one distributor.
(4) paragraph 2 (a) and (c) shall apply mutatis mutandis to intermediaries for medicinal products for human use. ';
19.
Spaces and technical equipment
(1) The distributor shall ensure that the premises, installations and facilities used for the storage and distribution of medicinal products correspond to the type and volume of the medicinal products distributed. In addition, they shall ensure that premises and technical equipment are organised, maintained and controlled to ensure the correct handling of medicinal products.
(2) The distributor shall ensure that premises used for the storage and distribution of medicinal products for human use, veterinary medicinal products, medicinal products and excipients are located only in non-residential areas meeting the general construction requirements and form an operationally sealed and functionally interconnected unit comprising:
(a) premises for the storage and handling of medicinal products for human use, veterinary medicinal products and medicinal and auxiliary substances with sufficient capacity,
(b) separate storage areas for addictive substances and medicinal products containing addictive substances, radiopharmaceuticals, gases used in the provision of health services and medicinal products, and medicinal and auxiliary substances kept at lower temperatures when distributed;
(c) separate premises for reception and delivery,
(d) the space for the deposit of claimed, returned, suspended, unregistered or withdrawn medicinal products and medicinal products for disposal;
(e) sanitary facilities for workers separated from the storage premises of medicinal products; and
(f) a closed area for cleaning and disinfection products.
(3) The distributor shall ensure that storage facilities for medicinal products are provided with technical equipment ensuring the safe handling and storage of stored medicinal products, ensuring safe handling and monitoring of storage conditions. Furthermore, the distributor shall ensure that the equipment used to monitor storage conditions is regularly checked and calibrated at least every 24 months.
(4) The distributor shall ensure that the repair, maintenance and calibration of all technical equipment is carried out in such a way as not to undermine the integrity of the medicinal products distributed.
(5) The distributor shall ensure that the IT and information systems used for record keeping and records are validated, have ensured data protection against unauthorised use and are regularly backed up in a renewable manner.
(6) On the basis of the risk assessment carried out, the distributor shall define the range of impacts and determine the scope of the assessment of the technical capability of the technical equipment used and the validation of the processes necessary for their proper installation and safe operation. Equipment and procedures shall be qualified and validated before they are put into service and at any significant change. ';
20. Paragraph 38 (1) reads:
"(1) The distributor shall develop and maintain up-to-date written procedures for activities which may affect the quality of medicinal products or distribution activities, such as ordering, checking of suppliers and customers, receiving, storage, supply, supply, return, withdrawal of medicinal products, checking of storage conditions, including the protection of medicinal products in storage and transport, cleaning and maintenance of premises and equipment, including extermination, validation and qualification of facilities and processes, risk management procedures and measures for the disposal of unused medicinal products, investigation and handling of complaints and complaints, including the establishment of adequate corrective and preventive measures, control of storage conditions and identification of medicinal products suspected of falsification."
21. In Paragraph 38, the following paragraphs 2 and 3 are inserted after paragraph 1:
"(2) The name, nature and purpose of each procedure referred to in paragraph 1 shall be indicated. The documentation shall be written clearly, approved by a qualified person, revised regularly and reviewed and made available to all staff members to the extent necessary for the performance of their tasks.
(3) The intermediary of medicinal products for human use shall draw up and maintain up-to-date written procedures for the control of intermediate medicinal products, supplying producers or distributors, customers, complaint handling and support for withdrawals, including the identification of medicinal products suspected of falsification. "
Paragraphs 2 to 6 shall be renumbered paragraphs 4 to 8.
22. in Paragraph 38 (4):
"(4) The distribution, purchase, sale or brokering activities, including internal controls, and complaints, withdrawals of medicinal products and complaints, and reviews thereof, shall be carried out by the distributor or intermediary in the form of records. The records included in the documentation shall preferably be kept in electronic form under the conditions laid down in Section 37 (5). ';
23. in Article 38 (5), the word "distributor" shall be inserted after the word "records."
24. in Paragraph 38 (5), the following point (e) is inserted after point (d):
"(e) if supplies are made to a customer who is the operator of a pharmacy and at the same time holds a marketing authorisation, the records shall include an indication of whether he is taking the medicinal products as a pharmacy or as a distributor."
Points (e) and (f) shall be renumbered as points (f) and (g).
25. in Paragraph 38 (5), the semicolon shall be replaced by "a" at the end of point (g) and the following point (h) shall be added:
"(h) where medicinal products have been facilitated, the identification of the intermediary by the information referred to in Article 77b (3) or (4) of the Medicines Act;"
26. in Paragraph 38 (5) of the final part of the provision, the text "(f)" is replaced by the text "(h)."
27. In Paragraph 38, the following paragraph 6 is inserted after paragraph 5:
"(6) Records of the intermediation of medicinal products for human use contain:
(a) the name of the medicinal product,
(b) the code assigned to the medicinal product by the Institute;
(c) the date of brokering the purchase or sale;
(d) identification of the supplier or customer;
(e) particulars of the quantity to be supplied and the identification of the medicinal products, enabling monitoring of the route of distribution of each product, including the period of application; and
(f) the lot number.
Each item referred to in points (a) to (f) shall be entered in the records by the intermediary so that they are not interchangeable. ';
Paragraphs 6 to 8 shall be renumbered paragraphs 7 to 9.
28. in Paragraph 38 (8), the following point (a) is added:
"(a) in the case of the distribution of lots originating in another Member State, a copy of the certificate of release of each batch of medicinal product signed by a qualified person of its manufacturer which he used to check before moving them to the sales stocks;"
Points (a) to (c) shall be renumbered (b) to (d).
29. in Paragraph 38 (8), at the end of point (e), the dot is replaced by a comma and the following points (f) to (h) are added:
"(f) a copy of the notification of the import of the medicinal product to the marketing authorisation holder and to the Institute pursuant to Article 77 (7) of the Drug Act;
(g) reporting on the volume of medicinal products distributed under Section 77 (1) (f) of the Drug Act;
(h) a copy of the notification of the distribution of the medicinal product outside the territory of the Czech Republic pursuant to § 77 (1) (q) of the Medicines Act. "
30. in Paragraph 38 (9), "2 to 5" is replaced by "4 to 8."
31. in Article 39 (2), the following points (c) and (d) are inserted after point (b):
'(c) the measuring equipment used to monitor the temperature during transport has been calibrated at least once every 12 months;
(d) the special conditions for their treatment, if any, are respected; and ';
Point (c) shall be renumbered as point (e).
32. in Paragraph 39 (4), the following point (e) is inserted after point (d):
"(e) the place of delivery;"
Points (e) to (g) shall be renumbered as points (f) to (h).
33.In Article 39 (4), the following point (g) is inserted after point (f):
"(g) in the case of a customer who is an operator of a pharmacy and at the same time holds a permit for distribution, whether to take medicines as a pharmacy or as a distributor,"
Points (g) and (h) shall be renumbered as points (h) and (i).
34. In Paragraph 39 (4) of the final part of the provision, the words ", where the veterinary institute so requests," and the text "(g) 'shall be replaced by" (i)'.
35. In Paragraph 39, the following paragraph 5 is inserted after paragraph 4:
"(5) The distributor shall establish a system for recording and reviewing complaints and complaints."
Paragraphs 5 to 9 shall be renumbered paragraphs 6 to 10.
36. in Paragraph 39 (6) (a), the words "unopened" shall be inserted after the words "original."
37. in Paragraph 39 (6), the following point (b) is inserted after point (a):
"(b) the person who returned it has demonstrated that it has been stored and transported under the conditions laid down by the manufacturer;"
Points (b) to (d) shall be renumbered (c) to (e).
38. in Paragraph 39 (6) (d), the word "customer" is replaced by the words "person redistributed,"
39. in Paragraph 39, the following paragraph 7 is inserted after paragraph 6:
"(7) The returned medicinal products shall be treated in accordance with the risk-based written procedure and, in respect of the medicinal product concerned, the specific conditions for its storage, if any, and the period from its delivery to the customer. ';
Paragraphs 7 to 10 shall be renumbered paragraphs 8 to 11.
40. In Paragraph 39 (9) of the Introductory Part of the provision, the words "or notified 'and the words" notified through regional offices' are deleted after the word "ordered '.
41. in Paragraph 39 (9), the following point (d) is inserted after point (c):
"(d) the procedure for ensuring the exchange of a medicinal product withdrawn because of a quality defect for a medicinal product without a quality defect, including the manner in which records of such exchange are kept and kept,";
Points (d) to (f) shall be renumbered as points (e) to (g).
42. In Paragraph 39 (9), at the end of point (g), the dot is replaced by "a 'and the following point (h) is added:
"(h) control and evaluation of the effectiveness of the download system at least once a year."
43.Paragraph 39 (10) reads as follows:
"(10) The distributor shall repeatedly carry out internal controls to verify the implementation and compliance with good distribution practice in all areas of distribution activity and take the necessary corrective action. Within the framework of internal controls, the distributor to whom the Institute or Veterinary Institute has issued a permit for the distribution of medicinal products shall carry out a detailed audit at least once a year to compare the state of all received and dispatched medicinal products with the current state of storage of medicinal products. The results of the comparison according to the second sentence, including, where appropriate, the irregularities detected in the framework of that comparison, shall be recorded in accordance with Paragraph 38 (4). ';
44. In Article 40 (2), the words "containing the particulars referred to in Article 28 (c) 'are deleted.
45. In Paragraph 40, the following paragraph 4 is inserted after paragraph 3:
"(4) The distributor of active substances and excipients supplied to persons authorised to prepare medicinal products supplies only those active substances or excipients whose quality has been verified in accordance with the requirements of the European Pharmacopoeia under Section 11 (c) of the Drug Act; if the substance is not listed in the European Pharmacopoeia, in accordance with the requirements of the Czech Pharmacopoeia pursuant to § 11 (d) of the Act on Medicines or Pharmacopoeia of another Member State and in cases where it is not listed in either of these pharmacopoeia, according to the requirements of the pharmacopoeia of a third country. The evidence of verification of the quality of the active substance or of the excipients supplied to persons authorised to prepare medicinal products in accordance with paragraph 2 shall include at least:
(a) the name of the substance;
(b) reference to the test standard or the Regulation;
(c) the lot number,
(d) the period of application;
(e) an indication of the representativeness of the sample used for testing;
(f) scope of testing, including test limits;
(g) the results of each test;
(h) the end of the test;
(ch) the date of issue of the document; and
(i) the identification number of the quality verification document, including the registration number of the control laboratory. ';
Paragraphs 4 and 5 shall become paragraphs 5 and 6.
46. in Paragraph 40 (5):
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Regulation Information
| Citation | Decree No. 252 / 2018 Coll., amending Decree No. 229 / 2008 Coll., on the Production and Distribution of Drugs |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 07.11.2018 |
|---|---|
| Effective from | 01.01.2019 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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