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.
