Decree No. 255 / 2013 Coll.
Decree amending Decree No. 228 / 2008 Coll., on the Registration of Medicinal Products, as amended
Valid
Order
Effective from 01.09.2013
Text versions:
01.09.2013
19.08.2013
255
DECLARATION
of 13 August 2013
amending Decree No. 228 / 2008 Coll., on the Registration of Medicinal Products, as amended
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 Laws (Act on Medicines), as amended by Act No. 50 / 2013 Coll. and Act No. 70 / 2013 Coll., for the implementation of § 2 (2) (c), § 8 (5), § 26 (5) (n), § 26 (7), § 27 (5), § 17 (12), § 28 (1) (c), § 28 (3), § 29 (2), § 30 (3) and § 33 (3), § 33 (g) (f), § 44 (f), § 45 (1), § 49 (1), § 37 (1), § 37 (3) to (5), § 38, § 40 (2) (f), § 40 (3), § 44 (3), § 33 (f), § 44 (f), §.
Decree No. 228 / 2008 Coll., on the Registration of Medicinal Products, as amended by Decree No. 13 / 2010 Coll. and Decree No. 171 / 2010 Coll., is amended as follows:
1. In Paragraph 1 (2), at the end of point (e), the comma is replaced by a dot and point (f) is deleted.
2. Paragraph 3 (1), including footnote 19, reads as follows:
"(1) Applications and other documentation submitted by the Institute for Human Products or the Veterinary Institute for Veterinary Products shall be submitted in electronic form unless otherwise agreed with the Institute for Human Products or the Veterinary Institute for Veterinary Products in specific cases. In the case of medicinal products for human use, the eCTD or NeeS19 electronic format shall be used for the processing of the application and other documentation in electronic form, as specified by the Institute; This format shall also apply to information and reports submitted under this Decree in electronic form of the Constitution. In the case of veterinary medicinal products, the VNees electronic format shall be used, unless otherwise agreed with the Veterinary Institute in specific cases.
19) Annex No 1 to Directive 2001 / 83 / EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. '
3. in Article 3 (6) (a) (2), the words "put into circulation" shall be replaced by the words "on the market."
4. in Articles 3 (6) (a) (3) and (5), 3 (6) (b) and 11 (h), the words "put into circulation" shall be replaced by "on the market."
5. In Article 3 (6) (b) (2), "a 'is replaced by" or' and "into circulation 'is replaced by" on the market'.
6. in § 3 (6) (b) (6):
"6. the essential information to be considered as the name of the product, strength, pharmaceutical form, active substance, the holder of the marketing authorisation, the storage method and the shelf life correspond to the conditions of the marketing authorisation in the Czech Republic and may be derived from the text in a foreign language or be supplemented on the packaging in the Czech language,"
7. In Paragraph 3 (7), "12 'is replaced by" 5'.
8. in Article 4 (a), the words "or, where applicable, further applications for a marketing authorisation, where a change is requested pursuant to Article 8 (9), significantly changing the existing marketing authorisation of a product authorised following a separate application" shall be deleted.
9. In Article 4, at the end of point (e), the dot is replaced by a comma and the following point (f) is added:
"(f) an application for registration of a specific medicinal product for human use under Section 28a of the Drug Act."
10. In Article 5, the following paragraph 9 is added:
"(9) The application for registration of a specific human homeopathic medicinal product authorised under Section 28a of the Drug Act shall be submitted in accordance with Annex 1 to this Decree. In Module 3 of Part I of Annex 1 to this Regulation, the data referred to in Part III, point 3 of Annex 1 to this Regulation shall be submitted. ';
11. in Article 6 (3), the words "without a prescription or" and the words "or without restrictions" shall be inserted after the words "supply of a human product."
12. in Article 6 (4), "(l)" is replaced by "(n)";
13.
Amendments to the marketing authorisation
In the case of an application for a change to the method of dispensing a medicinal product to a prescription without a prescription or without a prescription with a restriction or classification as a reserved medicinal product, the documentation submitted shall comply with the requirements set out in Annex 6 to this Regulation. '
14. In Paragraph 9, the present text becomes paragraph 1.
15. in Article 9 (1) (d), in point 1, "§ 91 (1)" is replaced by "§ 91a";
16. in Article 9 (1) (e):
"(e) proposals for a summary of product characteristics, package leaflet, packaging and models of all the outer and inner packaging in which the product is to be placed on the market, including colour graphic presentation, containing the name of the person to whom the decision is to be transferred; in addition to the particulars concerned by the transfer of the marketing authorisation, the draft summary of product characteristics, package leaflet and packaging particulars shall be identical to the approved summary of product characteristics, package leaflet and particulars on the packaging of the product. ';
17. in Paragraph 9 (2):
"(2) In addition to the information provided for in paragraph 1, a plan for the transfer of pharmacovigilance obligations under Title V of the Law from the existing marketing authorisation holder to the person to whom the decision is to be transferred shall be submitted. The transfer plan shall include, in particular, a formalised way of reporting adverse reactions during the period when products with old contact data are on the market, a plan to ensure continuity of reassessment of the benefit / risk balance, and a way of transferring pharmacovigilance data and other relevant information. ';
18. In Paragraph 10 (1), the second and third sentences are replaced by the following: "The new code shall be assigned in the event of a change to the name of the medicinal product, the package size and the type of packaging, and in the case of a transfer of registration, taking over the registration and simultaneous importation."
19. in Article 11, the following points (e) and (f) are inserted after point (d):
"(e) a summary of the pharmacovigilance system, an updated risk management plan and an addendum to the clinical review and non-clinical review, to the extent specified in the Constitution guideline,
(f) in the case of a medicinal product for human use, a summary of the pharmacovigilance system, an updated risk management plan and an addendum to the clinical review and non-clinical review, to the extent specified in the Constitution guideline, ';
Points (e) to (i) shall be renumbered as points (g) to (k).
20. In Article 11, the words "the addendum to the overall quality summary containing 'are inserted at the beginning of point (g).
21. in Article 11 (h) and (i):
"(h) in the case of a veterinary medicinal product:
1. a statement by a clinical expert assessing the current risk-benefit balance of the product, including an assessment of the consequences of the procedure; This statement shall be made by the expert on the basis of comprehensive data and documentation on the medicinal product concerned, the information contained in the periodic safety update reports and any publicly available data; in the declaration, the expert shall confirm that no new preclinical or clinical data are available to influence the evaluation of the current risk-benefit balance of the product,
2. a statement by the safety expert assessing the safety of the user and, where the veterinary medicinal product is authorised for animals from which products for human consumption are obtained, the safety for consumers of foodstuffs obtained from treated animals; the expert statement summarises all new relevant information for the period under assessment; the expert shall also take into account the risk-benefit assessment of the use of the veterinary medicinal product for the environment;
3. the expert statement referred to in points 1 and 2 shall contain a clear statement as to whether the marketing authorisation may be extended for an unlimited period or only for a further period of 5 years, or, where appropriate, under which conditions, including justification; where this condition consists in making a change to the Summary of Product Characteristics aimed at ensuring a favourable benefit balance and the risk of its use, such change may be made in the context of the renewal of the marketing authorisation without a separate application for the modification of the marketing authorisation being submitted; the declaration shall be signed by the competent expert and shall be accompanied by brief information on the education, training and professional experience of the expert,
(i) in the case of a veterinary medicinal product, a periodic safety update report to cover the entire period from the issue of the marketing authorisation or the last renewal of the marketing authorisation following the periodic safety update already submitted. Where this period is covered by more periodic updates of product safety reports, an additional report or a summary bridging report shall be submitted to the Veterinary Institute, as appropriate, in accordance with the instructions of the Commission and the Agency, '.
22. In Article 11 (j), "copies of approved specifications' is replaced by" approved specifications';
23. In the second sentence of Article 13 (3), the words "the reference product in the Czech Republic, holder of the authorisation for parallel imports' are inserted after the words" the marketing authorisation holder '.
24. In the fourth sentence of Article 13 (3), the words "To be completed 'are replaced by the words" To be added to the outer packaging' and the words "and the holder of the parallel import authorisation 'are deleted.
25. Paragraph 13 (4) reads:
"(4) Where the imported product is repackaged in a new outer packaging, it shall bear the particulars set out in Annex 5 to this Regulation and the particulars referred to in paragraph 3. ';
Article 26 (14) is deleted;
27. in Article 15 (5), the word "serious" shall be deleted;
28. in Article 17 (1) (e):
"(e) a study protocol containing at least information on the purpose, organisation, blindness, extent, population and objectives of the study and the way in which data are processed; and";
29. After Paragraph 17, the following Section 17a is inserted:
Information on the initiation or termination of a non-interventional post-authorisation safety study for medicinal products for human use
(1) The marketing authorisation holder shall inform the Institute electronically of the intention to conduct a non-interventional post-authorisation safety study under Section 93j of the Drug Act at least 60 days before the date of the study, and shall communicate the following information to the Institute:
(a) the name or business name and registered office of the marketing authorisation holder;
(b) identification of the product to be studied by the code assigned by the Institute;
(c) name of the study;
(d) the study identification number chosen by the marketing authorisation holder;
(e) the date of start of data collection, the estimated date of end of data collection, the completion of analyses and the transmission of the final report; and
(f) study protocol.
(2) The marketing authorisation holder shall electronically inform the Institute of the termination of the non-interventional post-authorisation safety study characterised by the study identification number assigned by the Institute, indicating the date of termination of the data collection. '.
30. Paragraph 19 shall be deleted, including the title.
31. In Annex 1, Part In point 1, the following point 1.7 is inserted after point 1.6:
"1.7 Information on exclusive market law for orphan medicinal product '.
Point 1.7 is renumbered point 1.8.
32. Point 1.8 of Part I of Annex 1 reads as follows:
"1.8. Risk management system and a description of the way in which pharmacovigilance is ensured
Applications for authorisation shall contain a summary of the pharmacovigilance system and a risk management plan describing the risk management system.
The risk management plan shall include:
(a) the safety specification;
(b) a pharmacovigilance plan,
(c) a plan for post-marketing efficacy studies;
(d) risk minimisation measures; and
(e) a summary of the risk management plan. ';
33. In Annex 1, Part the following points 1.9 and 1.10 are added to point 1:
"1.9 Information about clinical trials
Information on use in the paediatric population '.
34. In Annex No 1, Part III, point 3, in the introductory part of Module 3, the words "and when registering specific homeopathic products' shall be inserted after the words" homeopathic products'.
35. In Annex No 3, Part A, the first sentence is replaced by the following: "In the case of medicinal products listed in Article 23 of Regulation (EC) No 726 / 2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, as amended by Regulation (EC) No 1901 / 2006 of the European Parliament and of the Council, the sentence shall be inserted:" This medicinal product is subject to further monitoring. 'This sentence shall be preceded by the black symbol referred to in Article 23 of Regulation (EC) No 726 / 2004 and followed by an appropriate explanation.';
36. In Annex 3, Part A, in the heading of point 2, the word "i 'is replaced by" a' after the word "qualitative '.
37. In Annex 3, Part The following sentence is inserted after the first sentence: "In the case of specific homeopathic preparations registered under Section 28a of the Medicines Act, the scientific name of the basic substance or basic substances followed by the degree of dilution shall be given, using the pharmacopoeia symbol to express this degree. '
38. In Annex 3, Part A, at the end of point 4.1, the sentence "In the case of specific homeopathic products authorised under Section 28a of the Drug Act, the sentence" Homeopathic medicinal product used traditionally in homeopathy for mitigation "or" Homeopathic medicinal product used traditionally in homeopathy for treatment "shall be added, together with the relevant indication. ';
39. In Annex 3, Part A, the heading of point 4.6 reads:
"4.6 Fertility, pregnancy and breast-feeding."
40. In Annex 3, Part A, at the end of point 4.8, the sentence "The standardised text specifically requesting healthcare professionals to report any suspected adverse reaction in accordance with the national reporting system shall be added. ';
41. In Annex 3, Part A, point 6.5, the word "size 'is replaced by the word" content'.
42. In Annex No 4, Part A, the following sentence is inserted after the first sentence: "In the case of medicinal products listed in Article 23 of Regulation (EC) No 726 / 2004, the sentence" This medicinal product is subject to further monitoring. "This sentence shall be preceded by the black symbol referred to in Article 23 of Regulation (EC) No 726 / 2004 and followed by an appropriate standardised explanation. ';
43. In Annex 4, Part In the case of specific homeopathic products authorised under § 28a of the Drug Act, the name of the preparation consisting of the scientific name of the basic substance or of the basic substances followed by the degree of dilution shall be added to the package leaflet in addition to the clear indication of the term "homeopathic medicinal product ', using a pharmaceutical symbol and pharmaceutical form to express this degree; where the name of the product is fictional, the scientific name of the basic substance or of the basic substances followed by the degree of dilution shall be added in addition to the pharmaceutical form.'
44. In Annex 4, Part In point 2, at the end of the text of point (c), the words "; in the case of specific homeopathic preparations registered in accordance with Section 28a of the Medicines Act, the scientific name of the basic substance or basic substances followed by the degree of dilution shall be added, using a pharmacopoeia symbol and a qualitatively expressed content of the excipients in the Czech nomenclature for each variant of the preparation '.
45. In Annex 4, Part In point 2, at the end of the text in point (f), the words "; in the case of specific homeopathic medicinal products authorised under Section 28a of the Drug Act, the sentence" A homeopathic medicinal product used traditionally in homeopathic treatment "or" A homeopathic medicinal product used traditionally in homeopathic treatment "shall be added, together with the relevant indication. '
46. In Annex 4, Part In point 2, at the end of the text in point (o), the words "the standardised text explicitly requesting patients to report any suspected adverse reaction to their healthcare professionals or to their national reporting system directly in accordance with the national reporting system 'shall be added.
47. in Annex 4, Part A, point 2 (q), point 4 (k) and Annex 5, Part A, point 1 (f) and point 4 (f), the words "reach and sight" are replaced by the words "surveillance and reach."
48. In Annex No 4, Part A, point 4, the word "medicinal 'is inserted after the word" homeopathic'.
49. In Annex 4 (A) (4), point (n) is deleted.
Points (o) and (p) shall be renumbered as points (n) and (o).
50. in Annex 5 (A) (1) (a) and (b):
"(a) the name of the medicinal product followed by its strength and pharmaceutical form and, where appropriate, whether it is intended for use by infants, children or adults; if the product contains up to 3 active substances, an international non-proprietary name (in the Latin version of INN) or, in the absence thereof, a common name shall be added; in the case of specific homeopathic preparations registered under Section 28a of the Drug Act, in addition to the clear mention of the words" homeopathic medicinal product 'in the package leaflet, the name of the preparation consisting of the scientific name of the basic substance followed by the degree of dilution, using the pharmacopoeia symbol and the pharmaceutical form to express this degree; where the name of the product is fictional, the scientific name of the basic substance or of the basic substance followed by the degree of dilution shall be added in addition to the pharmaceutical form,
(b) a qualitative and quantitatively expressed content of the active substances in the unit of the dose or according to the form administered in the volume or weight, using their common Latin versions; in the case of specific homeopathic products registered under Section 28a of the Drug Act, the scientific name of the basic substance or of the basic substances followed by the degree of dilution, using the pharmacopoeia symbol to express that degree, ';
51. in Annex 5 (A) (2) (a) (1):
"1. The name of the medicinal product followed by its strength and pharmaceutical form and, where appropriate, whether to use it for infants, children or adults; if the product contains up to 3 active substances, an international non-proprietary name (in the Latin version of INN) or, in the absence thereof, a common name shall be added; in the case of specific homeopathic preparations registered under § 28a of the Drug Act, the name of the preparation consisting of the scientific name of the basic substance followed by the degree of dilution, using the Pharmacopoeia symbol and the pharmaceutical form to express this degree; where the name of the product is fictional, the scientific name of the basic substance or of the basic substances followed by the degree of dilution shall be supplemented in addition to the pharmaceutical form; ';
52. In Annex 5, Part In point 4, the word "medicinal 'shall be inserted after the word" homeopathic' and the word "indicate 'shall be replaced by the words" provide only the following information'.
53. In Annex 5 (A) (4) (p):
"(p) the information" Homeopathic medicinal product without approved therapeutic indications. "'
54. In Annex 5, Part A, the following point 5 is inserted after point 4:
"5. In the case of advanced therapy medicinal products to be used within the permitted hospital exemption, in addition to the clear mention of the words" Use within the hospital exemption ', the labelling on the packaging shall indicate:
(a) name,
(b) the lot number,
(c) expiration date;
(d) the method of use;
(e) the manufacturer's designation; and
(f) storage conditions. ';
Points 5 to 9 shall be renumbered 6 to 10.
55. In Annex 6, point 2 (i), the words "may be included in the free-for-sale medicinal products' are replaced by" may be issued without a prescription '.
56. Point 3 of Annex 6 reads as follows:
'3. Reasons why no prescription may be limited; it shall be demonstrated that the medicinal product cannot constitute a danger to human health or that prior technical advice with the pharmacist is not necessary for the proper use of the medicinal product, in particular specific warnings on contraindications, interactions, adverse effects, the need for medical checks. ';
57. In Annex 6, point 4, the word "period 'is replaced by" length' and the words ", where applicable, the efficacy data of the product when used under the conditions of dispensation without prescription 'are deleted.
(58) Annexes 7 and 8 are deleted.
Transitional provisions
1. The production of medicinal products not complying with the packaging requirements of Annex 5 to Decree No. 228 / 2008 Coll., as effective after the date of entry into force of this Order, may be allowed for a maximum period of 6 months after the date of entry into force of this Order.
2. Medicinal products manufactured in a version which does not comply with the requirements for placing on the packaging referred to in Annex 5 to Decree No. 228 / 2008 Coll., as effective after the date of entry into force of the Decree, may continue to be placed on the market, distributed, issued and used in the provision of health services for the duration of their application.
3. The marketing authorisation holder of a medicinal product listed in Article 23 of Regulation (EC) No 726 / 2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, as amended by Regulation (EC) No 1901 / 2006 of the European Parliament and of the Council, shall ensure that the data in the summary of product characteristics and package leaflet comply with the requirements of Decree No 228 / 2008 Coll. as effective after the date of entry into force of that decree by 31 December 2013 at the latest.
4. The holder of a marketing authorisation for a medicinal product not listed in accordance with Article 23 of Regulation (EC) No 726 / 2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, as amended by Regulation (EC) No 1901 / 2006 of the European Parliament and of the Council, shall ensure that the data in the summary of product characteristics and package leaflet comply with the requirements of Decree No 228 / 2008 Coll. as effective after the date of entry into force of that decree by 1 April 2016 at the latest.
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. 255 / 2013 Coll., amending Decree No. 228 / 2008 Coll., on the Registration of Medicinal Products, as amended |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 19.08.2013 |
|---|---|
| Effective from | 01.09.2013 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
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