Amendment Of The Decree On The Registration Of Medicinal Products

Original Language Title: změna vyhlášky o registraci léčivých přípravků

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255/2013 Sb.



DECREE



of 13 October. August 2013,



amending Decree No. 228/2008 Coll., on registration of medicinal products

preparations, as amended



The Ministry of health and Ministry of agriculture lays down pursuant to §

paragraph 114. 2 Act No. 378/2007 Coll., on pharmaceuticals and on changes of some

related laws (law on medicinal products), as amended by Act No. 50/2013 Coll.

and Act No. 70/2013 Coll., to implement section 2 (2). 2 (a). (c)), § 8 para. 5,

§ 26 para. 5 (b). n), § 26 para. 7, section 27 para. 5, 7, 11 and 12, section 28

paragraph. 1 (b). (c)), § 28 para. 3, § 29 para. 2, § 30 paragraph 2. 3 and 7, § 32

paragraph. 3, § 33 para. 3 (b). g) in point 4, § 34 paragraph 1. 1, § 36 odst. 1, § 37

paragraph. 1 to 3, 5 and 6, § 38, § 40 paragraph 2. 2 (a). (f)), section 40 para. 3, § 44

paragraph. 3 and 9 (b). (f)), § 45 para. 7 (b). (b)), § 49 para. 5 of the law on

pharmaceuticals:



Article. (I)



Decree 228/2008 Coll., on registration of medicinal products, as amended by

Decree No. 13/2010 Coll. and Decree No. 171/2010 Coll., is amended as follows:



1. In article 1 (1). 2 at the end of paragraph (e)) the comma is replaced by a dot and the

the letter f) shall be deleted.



2. in section 3, paragraph 1, including footnote # 19 is added:



"(1) the application and other documentation to be submitted to the Institute, in the case of human

products, or Veterinary Institute, in the case of veterinary medicinal products,

must be submitted in electronic format, if in the Special

cases, not with the Institute, in the case of medicinal products for human use or with

The animal health Institute, in the case of veterinary medicinal products, unless otherwise agreed.

In the processing of applications and other documents in electronic form in

the case of the medicinal products for human use uses the electronic format of the eCTD or

Nees ^ 19) according to the instructions of the Institute; This format is used for information and

report submitted pursuant to this order in electronic form. In

the case of veterinary medicinal products shall apply the electronic format

VNees, unless in special cases with the Veterinary Institute agreed

otherwise.



19) Annex No. 1 of European Parliament and Council Directive 2001/83/EC of

January 6. November 2001 on the Community code relating to human

medicinal products. ".



3. In article 3, paragraph 3. 6 (a). and (2) the words of) "that come into circulation"

replaced by the words "on the market".



4. In article 3, paragraph 3. 6 (a). and) points 3 and 5, § 3 para. 6 (a). (b)) and § 11

(a). (h)), the words "in circulation" shall be replaced by "on the market".



5. In section 3, paragraph 3. 6 (a). (b)) (2) the word "and" shall be replaced by "or", and

the words "put into circulation" shall be replaced by the words "on the market".



6. In section 3, paragraph 3. 6 (a). (b)) point 6 is added:



"6. the basic data, which is the product name, strength, dosage

form, active substance, the marketing authorisation holder, method of preservation

and shelf life, the comply with the conditions of registration in the Czech Republic

and can be from a text in a foreign language to derive or are on the packaging in the Czech

language added, ".



7. in section 3, paragraph 3. 7, the number "12" is replaced by "5".



8. In paragraph 4 (b). a), the words ", where appropriate, further requests for registration,

If a request for amendment under section 8 (2). 9, significantly changing the existing

the registration of a registered under a separate application "

shall be deleted.



9. In paragraph 4, at the end of paragraph (e)) dot replaced with a comma and the following

subparagraph (f)), which read as follows:



"(f) a request for registration of the specific) for a homeopathic medicine

According to § 28a of law on pharmaceuticals. ".



10. in paragraph 5, the following paragraph 9 is added:



"(9) with a request for the registration of a specific homeopathic

a medicinal product authorised under section 28a of the law on pharmaceuticals,

submit the documentation referred to in annex 1 to this notice. In module 3

under part I of the annex 1 to this notice shall be submitted to the data referred to in

Part III, section 3 of annex 1 to this Ordinance. ".



11. In paragraph 6 (1). 3, after the words "issue of humane medicine"

the words "without a prescription or" and the words "or without limits"

shall be deleted.



12. in section 6 (1). 4, the words "(a). l) "are replaced by the words" (a). n) ".



13. section 8 including the title reads as follows:



"section 8



Registration changes



In the case of a request for change in the way the issue of preparation of the picking route

prescription for dispensing without prescription or dispensing without

a prescription with a restriction or classification between dedicated healing

products must meet the requirements of the dossier referred to in

Annex No 6 to this Ordinance. ".



14. in article 9 the present text shall become paragraph 1.



15. in § 9 para. 1 (b). d), in point 1, the words "section 91 paragraph 2. 1 "shall be replaced by

the words "§ 91a".



16. in § 9 para. 1 letter e) is added:



"(e)) the draft summary of product characteristics, package leaflet,

listed on the packaging, and designs of all external and internal packaging, in

which the product should be placed on the market, including the colorful graphics editing,

containing the name of the person to whom the transfer is to be transferred; In addition to the

affected by the transfer of registration data shall be the summary of proposals

product characteristics, package leaflet and the indications on the packaging of the content

identical with the approved summary of product characteristics and package leaflet

and the details given on the packaging of the product. ".



17. in section 9, paragraph 2 reads as follows:



"(2) in the case of a veterinary medicinal product shall be submitted in addition to the data referred to in

paragraph 1 and plan the transfer of responsibilities in the area of pharmacovigilance by

Title V of the law of the existing marketing authorisation holder, the person

on which the decision is to be transferred. Plan the transfer of obligations contains

in particular, a formalized method of passing reports of adverse effects in the

the period when they are on the market, with the old contact information, schedule

ensure continuity in the re-evaluation of the benefit/risk ratio, and the way

the transfer of the data on pharmacovigilance and other relevant information. ".



18. in section 10, paragraph 1. 1, the second and third sentences shall be replaced by the phrase "the new code will

in case of changes in the name of the medicinal product, the size of the packaging and

the kind of packaging and furthermore in the case of the transfer of registration, acceptance and registration

in the parallel imports. ".



19. in paragraph 11, point (d)) the following point (e)), and (f)), which read as follows:



"e) summary of the pharmacovigilance system, the updated risk management plan

and addendum to the clinical summary and overview neklinickému, and in

the scope of the guidance of the Institute,



f) in the case of medicine, the total of the pharmacovigilance system,

an updated risk management plan and amendment to a clinical overview

neklinickému review, and to the extent provided for under the guidance of the Institute ".



Subparagraph (e))) to (i) shall become letters (g))).



20. In paragraph 11, at the beginning of subparagraph (g)), the words "Supplement to the overall

a summary of the quality that contains ".



21. in paragraph 11 (h)), and even letters):



"h) in the case of veterinary medicinal product



1. statement of the clinical expert that will evaluate the current risk

and the benefits of the product, including an assessment of the consequences of the way issues;

This Declaration will make on the basis of expert of integrated data and documentation

the medicinal product, the information contained in the periodic

updated reports on the safety of the product, and all publicly

the available data; in a statement the expert confirms that there are no

new preclinical or clinical data that could affect the evaluation of the

the current risk-benefit ratio of the product,



2. an expert statement on safety, in which it shall assess the safety

for the user, and if the veterinary product is authorised for animals,

from which they are derived products for human nutrition,

safety for the consumer of foodstuffs obtained from treated animals;

an expert statement summarizes all new relevant information for the period

that is the subject of reviews; in the context of the assessment of the risk

the benefit of the use of the veterinary medicine expert also takes account of the risk

for the environment,



3. an expert statement pursuant to sections 1 and 2 shall include a clear representation to

whether the marketing authorisation may be extended for an unlimited period

or only for the next 5 years, as appropriate, under what conditions, including

justification; If this condition lies in the implementation of changes in the summary

the product information to ensure a favourable benefit

of the product and the risk of its use, can be such a change to take place in the

under the renewal, without being submitted to a separate

application for amendment of registration; the Declaration must be competent expert

signed and attached brief information about education, training and professional

the experience of an expert,



I) in the case of veterinary medicinal product periodically for an updated report on the

safety of the product, to building on the already submitted for periodic

updated report on the safety of the veterinary medicinal product is covered

the entire period from the issue of a marketing authorisation or the last

renewal of the authorisation. If this period is covered by multiple periodic

updated news about the safety of the product, the

The Veterinary Institute under the scope of the supplementary report, or

summary the overarching message in accordance with the instructions of the Commission and the agencies. "



22. in paragraph 11 (a). j), the words "a copy of the approved specifications" are replaced by

the words "approved".




23. in § 13 para. 3 the second sentence, after the words "the holder of the

the registration of ", the words" of the reference product in the Czech Republic,

holder of the authorisation the parallel imports ".



24. In § 13 para. 3 of the fourth sentence, the words "make up" are replaced by the words

"Furthermore, the outer packaging shall indicate the" and the words "and the holder of the authorisation the parallel

imports "shall be deleted.



25. in section 13 paragraph 4 is added:



"(4) if imported into the repackaging of the product in new external

the package, the data referred to in annex No. 5 to this Decree and

at the same time the information referred to in paragraph 3. '.



26. section 14 is repealed.



27. in article 15, paragraph 2. 5, the word "serious" is deleted.



28. in § 17 paragraph 2. 1 letter e) is added:



"e) study protocol that contains a minimum of information about the purpose,

the arrangement, blinding, extent, population and the objectives of the study and

the method of data processing, and ".



29. in paragraph 17 of section 17a shall be inserted, which including the title reads as follows:



"§ 17a



Information on starting or their non-Interventional post-authorisation studies

the safety of medicinal products



(1) the marketing authorisation holder shall inform at least 60 days before the date of

begin study Institute of the intention to electronically non-Interventional

Post-authorisation safety study under § 93j law on pharmaceuticals, and shall communicate

The Institute the following information:



a) name or business name and address of the marketing authorisation holder,



(b)) product identification, which should be the subject of study, the code that

is allocated to the Institute of medicine,



(c) the name of the study)



(d) the identification number of the studies selected) the holder of a

the registration,



e) start date of the collection of data, the estimated date of completion of data collection,

completion of the analysis and transmission of the final report and



f) study protocol.



(2) the marketing authorisation holder shall inform the Institute about electronically

termination of non-Interventional post-authorisation safety studies

characterized by the identification number allocated to the study by the Institute with the

the date of the termination of the collection of data. ".



30. section 19, including the title.



31. in annex 1, part I, point 1, the following point shall be inserted after point 1.6 1.7,

which reads as follows:



"1.7 information about exclusivity on the market for the medicinal product for

rare diseases ".



Point 1.7 shall become item 1.8.



32. In annex 1, part I, point 1, point 1.8 is added:



"1.8 the risk management system and a description of the manner of pharmacovigilance



Applications for registration shall contain a summary of the pharmacovigilance system and

a risk management plan that describes the risk management system.



The risk management plan includes:



and Security specification)



(b) the pharmacovigilance plan),



c) plan of the post-efficiency,



d) measures to minimise the risks and



e) a summary of the risk management plan. "



33. In annex 1, part I, point 1, the following points, 1.9 and 1.10, which

shall be added:



"1.9 information about clinical trials



1.10 Information on use in the paediatric population ".



34. In annex 1, part III, point 3, in the introductory section of module 3, the words

"homeopathic preparations", the words "and when you register

specific homeopathic products ".



35. in annex 3, part A, in the first sentence shall be inserted after the phrase "summary

the product must in the case of medicinal products on the list

According to article 23 of the regulation of the European Parliament and of the Council (EC) No 726/2004

of 31 March 2004. March 2004 laying down Community procedures for the

authorisation and supervision of medicinal products and veterinary medicinal products and laying

European Medicines Agency, as amended by regulation of the European

Parliament and of the Council (EC) no 1901/2006, contain the sentence: "this product

product is subject to further monitoring. " This sentence must be preceded by a black

a symbol referred to in article 23 of Regulation (EC) No 726/2004 and shall

follow the appropriate explanation. ".



36. in annex 3, part A, in the title of section 2, after the word "Quality"

the word "i" shall be replaced by "and".



37. in annex 3, part A, point 2, the first sentence shall be inserted after the phrase "in the

case of specific homeopathic medicinal products registered in accordance with section

28 the law on medicines, lists the scientific name of the stock or

stocks followed by the degree of dilution, using

the expression of this level, it's the symbol of the pharmacopoeia. ".



38. in annex 3, part A, at the end of section 4.1, the following sentence "in

case of specific homeopathic medicinal products registered in accordance with section

28 the law on pharmaceuticals, together with an indication of the relevant indication shows the sentence

"Homeopathic medicine used traditionally in homeopathy to

mitigation ", or" homeopathic medicine used traditionally in

homeopathy for treating ".".



39. in annex 3, part A, the heading of section 4.6:



"4.6 fertility, pregnancy and lactation".



40. in annex 3, part A, at the end of section 4.8 of the following sentence "shall be

standardized text explicitly requesting healthcare professionals to

to report any suspected adverse effects in accordance with national

reporting system ".



41. in annex 3, part A, in point 6.5 ' size ' is replaced by

the word "content".



42. in annex No 4 of part A shall be inserted after the first sentence, after the phrase "in the case of

medicinal products included on the list referred to in article 23 of Regulation (EC)

# 726/2004 must be further included the sentence: "this medicine

subject to additional monitoring. " This sentence must be preceded by a black

referred to in article 23 of Regulation (EC) No 726/2004 and shall follow the

suitable standardized explanations. ".



43. in annex No 4, part A, point 2, point (a) at the end of the text)

the words "; in the case of specific homeopathic products

registered under section 28a of the law on pharmaceuticals, in addition to the clear

putting the words "homeopathic medicinal product" in the package leaflet

the name of the product consisting of the scientific name of the basic substance or

stocks followed by the degree of dilution, using

the expression of this level, it's a symbol according to the pharmacopoeia and pharmaceutical form;

in the case that the name of the product is invented, in addition to the formulation of

the scientific name of the stock or stocks followed by the degree of

dilution ".



44. in annex No 4, part A, point 2, the text at the end of subparagraph (c))

the words "; in the case of specific homeopathic products

registered under section 28a of the law on pharmaceuticals scientific name base

substance or substances, followed by the degree of dilution, while

the expression of this level, it's a symbol according to the pharmacopoeia and

quality and the content of the excipients in the Czech chemical nomenclature,

for each presentation of the product ".



45. in annex No 4, part A, point 2, the text at the end of subparagraph (f))

the words "; in the case of specific homeopathic products

registered under section 28a of the law on medicinal products, together with an indication of

the indication shows the sentence "homeopathic medicinal product used

traditionally in homeopathy to relieve ", or" homeopathic medicinal product

used traditionally in homeopathy to treat ".



46. in annex No 4, part A, point 2, the text of the letter at the end)

the words "; standardized text shall explicitly requesting patients to

healthcare workers, or directly to the national system

reporting to report any suspected adverse effects in accordance with the

the national reporting system ".



47. in annex No 4, part A, point 2 (a). q), point 4 (b). k) and in the annex

# 5, part A, paragraph 1 (b). (f)) and paragraph 4 (b). f), the words "the reach and

supervision "shall be replaced by" supervision and reach ".



48. in annex No 4, part A, paragraph 4, after the word "homeopathic" is inserted

the word "medicine".



49. in annex No 4, part A, point 4, point (n)) shall be deleted.



Letters about) and p) are known as the letters n) and o).



50. in annex 5, part A, point 1, letter a) and (b)):



"and the name of the medicinal product), followed by its strength and pharmaceutical

form and, if appropriate, whether it is intended to be used for infants, children, or

adults; If the product contains up to three active substances, the

international non-proprietary name (in the Latin version of the INN) or, if

does not exist, the common name; in the case of specific homeopathic

products authorised under section 28a of the law on pharmaceuticals, in addition to

the clear mention of the words "homeopathic medicinal product" package

the information shall indicate the name of the product consisting of the scientific name of the base

the substance, followed by the degree of dilution, using the expression of this

to the degree it's the symbol of the pharmacopoeia and pharmaceutical form; in the case that the name of the

the product is invented, in addition to the formulation of the scientific name

basic substances or basic substances, followed by the degree of dilution,



b) qualitatively and quantitatively, and the content of the active substances in

per dosage unit or according to the form in a given volume or weight,

using their common names in the Latin version; in the case of

specific homeopathic medicinal products registered in accordance with section 28 of the Act

on the scientific name of the stock or stocks for


by the degree of dilution, using the expression of this degree

It's the symbol of the Pharmacopoeia, ".



51. In annex 5, part A, point 2 (a). and) point 1 shall read:



' 1. The name of the medicinal product followed by its strength and pharmaceutical

form and, if appropriate, whether it is intended to be used for infants, children, or

adults; If the product contains up to three active substances, the

international non-proprietary name (in the Latin version of the INN) or, if

does not exist, the common name; in the case of specific homeopathic

products authorised under section 28a of the law on pharmaceuticals product name

consisting of the scientific name of the stock, followed by the

the degree of dilution, using the expression of this level, it's the symbol of the

Pharmacopoeia and pharmaceutical form; in the case that the name of the product is invented,

make up in addition to the formulation of the scientific name of the stock or

stocks followed by the degree of dilution, ".



52. In annex 5, part A, paragraph 4, after the word "homeopathic" is inserted

the word "medicine" and the word "shall" shall be replaced by the words "only

the following information ".



53. In annex 5, part A, point 4, letter p) is added:



"p) information" homeopathic medicinal product without approved therapeutic

the indications ".".



54. In annex 5, part A, in point 4, the following point 5 is added:



"5. in the case of advanced therapy medicinal products which are to be

used within the allowed the hospital exemption, in addition to the clear

putting the words "use within the hospital exemption" in the labelling

stating the following:



and) name,



b) lot number,



(c)) the expiration date,



(d)) how to use,



(e) the manufacturer's name and)



f) storage conditions. ".



Items 5 to 9 shall be renumbered 6 to 10.



55. in annex No 6 (2). I), the words "may be inserted between the

over-the-counter medicinal products "shall be replaced by" may be issued without

a prescription ".



56. In annex 6, point 3 is added:



"3. the justification for dispensing without a prescription may not be limited;

demonstrate that the medicinal product cannot constitute a danger to health

people or for the correct use of the product is not necessary a previous

professional consultation with a pharmacist, and especially a special warning on

contraindications, interactions, side effects, need for medical

checks. ".



57. In annex 6, paragraph 4, the word "time" is replaced by "length" and

the words ", where appropriate, information on the efficacy of the product when used under the conditions

dispensing without prescription "shall be deleted.



58. the annexes 7 and 8 are deleted.



Article. (II)



Transitional provisions



1. To produce medicinal products not satisfying the requirements for the placing of the information

on the packaging in accordance with Annex No 5 of Decree No. 228/2008 Coll., in the version in force

After the effective date of this order, for a maximum period of 6 months after the

the effective date of this Ordinance.



2. medicinal products manufactured in a design that does not meet the

the information on the package in accordance with Annex No 5 of Decree No. 228/2008 Coll.

in the version in force after the date of entry into force of this Decree, may continue to be

to market, distribute, supply and use in the provision of

health services for the period of their application.



3. the holder of the marketing authorisation of a medicinal product referred to in

list referred to in article 23 of the regulation of the European Parliament and of the Council (EC) No.

726/2004 of 31 July. March 2004 laying down Community procedures

for the authorisation and supervision of medicinal products and veterinary medicinal products and laying

European Medicines Agency, as amended by regulation of the European

Parliament and of the Council (EC) no 1901/2006 shall ensure that the information in the summary

of product characteristics and package leaflet comply with the requirements of Decree No.

228/2008 Coll. in the version in force after the date of entry into force of this order

not later than 31 December 2006. December 2013.



4. the holder of the marketing authorisation of a medicinal product not covered by the

list referred to in article 23 of the regulation of the European Parliament and of the Council (EC) No.

726/2004 of 31 July. March 2004 laying down Community procedures

for the authorisation and supervision of medicinal products and veterinary medicinal products and laying

European Medicines Agency, as amended by regulation of the European

Parliament and of the Council (EC) no 1901/2006 shall ensure that the information in the summary

of product characteristics and package leaflet comply with the requirements of Decree No.

228/2008 Coll. in the version in force after the date of entry into force of this order

by 1. April 2016.



Article. (III)



The effectiveness of the



This Decree shall enter into force on 1 January 2000. September 2013.



Minister of health:



Mudr. Holcat, MBA, in r.



Minister of agriculture:



Ing. Toman in r.

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