natgillin/translations-raw huggingface dataset:
(7) Член 50а, параграф 2 се заменя със следния текст:
(7) Article 50a (2) is replaced by the following:
Комисията приема всяко изменение, което може да се окаже необходимо за адаптиране на разпоредбите от параграф 1 към научно-техническия прогрес.
The Commission shall adopt any amendments which may be necessary to adapt the provisions of Paragraph 1 to take account of scientific and technical progress.
Тези мерки, предназначени да изменят несъществени елементи на настоящата директива, се приемат в съответствие с процедурата по регулиране с контрол, посочена в член 89, параграф 2а.“
Those measures, designed to amend non-essential elements of this directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).”
Член 51 – параграф 1
Article 51 - paragraph 1
„Принципите и насоките за добра производствена практика на ветеринарни лекарствени продукти, посочени в член 50, буква е), се приемат от Комисията под формата на директива, адресирана до държавите-членки.
“The principles and guidelines of good manufacturing practice for veterinary medicinal products referred to in Article 50(f) shall be adopted by the Commission in the form of a Directive addressed to the Member States.
Тези мерки, предназначени да изменят несъществени елементи на настоящата директива, като я допълват, се приемат в съответствие с процедурата по регулиране с контрол, посочена в член 89, параграф 2а.“
Those measures, designed to amend non-essential elements of this Directive, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).”
Член 67 – буква а
Article 67 – point a a
„аа) ветеринарни лекарствени продукти, предназначени за животни, отглеждани за производство на храни.
“(aa) veterinary medicinal products for food-producing animals.
Въпреки това държавите-членки могат да разрешават изключения от това изискване съгласно критериите, установени от Комисията.
However, Member States may grant exemptions from this requirement according to criteria established by the Commission.
Тази мярка, предназначена да измени несъществени елементи на настоящата директива, като я допълва, се приема в съответствие с процедурата по регулиране с контрол, посочена в член 89, параграф 2а.
The establishment of those criteria, a measure designed to amend non-essential elements of this Directive, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).
Държавите-членки могат да продължат да прилагат националните разпоредби до:
Member States may continue to apply national provisions until either:
- датата на прилагане на решението, прието в съответствие с алинея първа; или
– the date of application of the decision adopted in accordance with the first subparagraph; or
- 1 януари 2007 година, ако до 31 декември 2006 година няма прието такова решение;“
– 1 January 2007, if no such decision has been adopted by 31 December 2006;”
Член 68 – параграф 3
Article 68 – paragraph 3
Комисията приема всяко изменение на списъка на субстанциите, посочен в параграф 1.
The Commission shall adopt any amendments to the list of substances referred to in paragraph 1.
Член 75 – параграф 6
Article 75 – paragraph 6
Комисията може да измени параграф 5 в светлината на опита, придобит от неговото действие.
The Commission may amend paragraph 5 in the light of the experience gained from its operation.
Член 79
Article 79
„Член 79
“Article 79
Комисията приема всички изменения, които може да се окажат необходими за актуализиране на разпоредбите на параграфи от 72 до 78 предвид научно-техническия прогрес.
The Commission shall adopt any amendments which may be necessary to update Articles 72 to 78 to take account of scientific and technical progress.
Член 88
Article 88
(13) Член 88 се заменя със следния текст:
(13) Article 88 is replaced by the following:
„Член 88
“Article 88
Комисията приема всички изменения, необходими за адаптирането на приложение І към научно-техническия прогрес.
The Commission shall adopt any changes which are necessary in order to adapt Annex I to take account of technical progress
Директива 2001/82/EО
Regulation 2001/82/EC
Член 89
Article 89
(14) Член 89 се изменя, както следва:
(14) Article 89 is amended as follows:
а) Прибавя се следният параграф 2а:
(a) The following paragraph 2a is inserted:
При позоваване на настоящия параграф се прилагат член 5а, параграфи 1–4 и член 7 от Решение 1999/468/ЕО, при спазване на разпоредбите на член 8 от него.“
Where reference is made to this paragraph, Article 5a (1) to (4) and Article 7 of Decision No 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof”.
б) Параграф 4 се заменя със следния текст:
(b) Paragraph 4 is replaced by the following:
Правилникът за работа на Постоянния комитет се прави обществено достояние.“
The rules of procedure of the Standing Committee shall be made public.”
Директива 2001/83/EО
Regulation 2001/83/EC
Член 23 б – параграфи 2 a и 2 б (нови)
Article 23 b - paragraph 2 a and 2 b (new)
Държавите-членки могат да продължават да прилагат националните разпоредби относно измененията, приложими от влизането в сила на настоящия регламент за прилагане по отношение са разрешителни за пускане на пазара, получени преди 1 януари 1998 г. за лекарствени продукти, които са разрешени единствено в дадената държава-членка.
Member States may continue to apply national provisions on variations applicable at the time of entry into force of this implementing regulation to marketing authorisations granted before 1 January 1998 to medicinal products authorised only in that Member State.
Когато даден лекарствен продукт, който е предмет на национални разпоредби в съответствие с настоящия член, впоследствие е получил разрешително за пускане на пазара в друга държава-членка, регламентът за прилагане се прилага за този лекарствен продукт от тази дата.
Where a medicinal product subject to national provisions in accordance with this A rticle is subsequently granted a marketing authorisation in another Member State , the implementing regulation shall apply to that medicinal product from that date.
Когато дадена държава-членка реши да продължи да прилага националните разпоредби съгласно предходния параграф, тя уведомява Комисията за това.
Where a Member State decides to continue to apply national provisions pursuant to the previous paragraph, it shall notify the Commission thereof.
Ако уведомлението не е извършено до [дата на транспониране на директивата за изменение], се прилага регламентът за прилагане.
If a notification has no t been made by [date of transposition of amending directive], the implementing regulation shall apply.
Директива 2001/83/EО
Directive 2001/83/EC
(1а) Добавя се следният член 23в:
( 1a ) The following Article 23c shall be inserted :
„Член 23в
“ Article 23 c
Подходящите мерки, приети от Комисията в съответствие с член 23б, трябва да отчитат следните елементи:
The appropriate arrangements adopted by the Commission in accordance with Article 23b must take the following considerations into account :
- по практически съображения за ефикасност във всички категории изменения следва да се включи възможността за подаване на единно заявление за едно или повече идентични изменения, внесени по отношение на няколко разрешителни за пускане на пазара;
- f or practical reasons of efficiency, the possibility should be extended to all the categories of change of submitting a single application for one or more identical changes made to the terms of a number of marketing authorisations ;
- по отношение на разширяването на обхвата на разрешителните за пускане на пазара следва да се предостави възможност, въз основа на предоставена обосновка, за подаване на отделно, пълно заявление за разрешение за лекарствен продукт, който вече е получавал разрешение под друго наименование и с различно обобщение на характеристиките на продукта.“
- as regards extensions of marketing authorisations, the possibility should be provided, on the basis of arguments in justification, of submitting a complete, separate application for authorisation for a medicinal product that has already been authorised under another name and with a different product characteristic summary.”
1er- Il parait important d’étendre aux autres catégories de modifications cette possibilité de soumission d’une demande unique.
1er- Il parait important d’étendre aux autres catégories de modifications cette possibilité de soumission d’une demande unique.
2e : Le système actuel prévoit la possibilité pour une extension de l’AMM, de présenter une demande d’autorisation complète et distincte pour un médicament qui a déjà été autorisé, mais sous une autre dénomination et avec un résumé des caractéristiques du produit différent.
2e : Le système actuel prévoit la possibilité pour une extension de l’AMM, de présenter une demande d’autorisation complète et distincte pour un médicament qui a déjà été autorisé, mais sous une autre dénomination et avec un résumé des caractéristiques du produit différent.
Il est essentiel de conserver cette possibilité.
Il est essentiel de conserver cette possibilité.
Certains noms de médicaments sont associés à une pathologie et être obligé de conserver le même nom pour une pathologie différente pourrait avoir un effet dommageable pour le patient.
Certains noms de médicaments sont associés à une pathologie et être obligé de conserver le même nom pour une pathologie différente pourrait avoir un effet dommageable pour le patient.
Държавите-членки въвеждат в сила законовите, подзаконовите и административните разпоредби, необходими за постигане на съответствие с настоящата директива, не по-късно от [ 12 месеца от датата на нейното влизане в сила].
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [ 12 months after entry into force] at the latest.
Държавите-членки въвеждат в сила законовите, подзаконовите и административните разпоредби, необходими за постигане на съответствие с настоящата директива, не по-късно от [ 18 месеца от датата на нейното влизане в сила].
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [ 18 months after entry into force] at the latest.
Те незабавно съобщават на Комисията текста на тези разпоредби и таблицата на съответствието между тези разпоредби и настоящата директива.
They shall forthwith communicate to the Commission the text of those provisions and a table showing the correlation between those provisions and this Directive.
Преходният период от 12 месеца е твърде кратък с оглед на значителните изменения по отношение на много национални разрешителни за пускане на пазара.
The transitional period of 12 months is too short in the light of the considerable changes for many national marketing authorisations.
Следователно е целесъобразно този срок да се удължи на 24 месеца.
It is therefore appropriate to extend this period to 24 months.
A number of aspects of a medicine may change during its life cycle.
A number of aspects of a medicine may change during its life cycle.
Technological progress, as well as new scientific data, offer the possibility of improving existing medicinal products.
Technological progress, as well as new scientific data, offer the possibility of improving existing medicinal products.
These changes can relate, for example, to the manufacturing process, purification methods or the introduction of a new therapeutic indication, not to mention updating of patient information leaflets to incorporate new safety information based on reported side-effects.
These changes can relate, for example, to the manufacturing process, purification methods or the introduction of a new therapeutic indication, not to mention updating of patient information leaflets to incorporate new safety information based on reported side-effects.
In addition, consolidation of the pharmaceutical industry via mergers and acquisitions gives rise to many administrative changes, such as changes to the names or addresses of pharmaceutical companies.
In addition, consolidation of the pharmaceutical industry via mergers and acquisitions gives rise to many administrative changes, such as changes to the names or addresses of pharmaceutical companies.
All of these changes are known as ‘variations’ and must be reported to the competent authorities by the holders of authorisations to market medicinal products.
All of these changes are known as ‘variations’ and must be reported to the competent authorities by the holders of authorisations to market medicinal products.
The pharmaceutical industry devotes a large part of its regulatory work to managing these variations.
The pharmaceutical industry devotes a large part of its regulatory work to managing these variations.
By way of example, in the case of a medium-sized company producing generic medicines and carrying a list of 400 products (including different pharmaceutical presentations and dosages), the total number of variations submitted would exceed 4 000 per year.
By way of example, in the case of a medium-sized company producing generic medicines and carrying a list of 400 products (including different pharmaceutical presentations and dosages), the total number of variations submitted would exceed 4 000 per year.
In the case of a large company, the number would be about 19 000.
In the case of a large company, the number would be about 19 000.
(2) Weakness of the current system of regulatory requirements relating to changes in marketing authorisations for medicinal products
( 2) Weakness of the current system of regulatory requirements relating to changes in marketing authorisations for medicinal products
The current way of managing variations is proving increasingly inefficient and is no longer satisfactory either for the authorities or for the pharmaceutical industry as a whole.
The current way of managing variations is proving increasingly inefficient and is no longer satisfactory either for the authorities or for the pharmaceutical industry as a whole.
Given that 80% of all human and veterinary medicinal products are authorised via national procedures, this revision will have a considerable impact on the pharmaceuticals market in the European Union.
Given that 80% of all human and veterinary medicinal products are authorised via national procedures, this revision will have a considerable impact on the pharmaceuticals market in the European Union.
The granting of purely national marketing authorisations is subject to the same regulatory requirements as marketing authorisations granted under European procedures.
The granting of purely national marketing authorisations is subject to the same regulatory requirements as marketing authorisations granted under European procedures.
The regulatory requirements for changing marketing authorisations, on the other hand, are not harmonised.
The regulatory requirements for changing marketing authorisations, on the other hand, are not harmonised.
Changes to purely national marketing authorisations take place in accordance with provisions specific to each Member State, which are different from the European regulatory requirements.
Changes to purely national marketing authorisations take place in accordance with provisions specific to each Member State, which are different from the European regulatory requirements.
Any one change to products authorised under national procedures in different Member States is therefore treated in a number of different ways in terms of the dossier to be submitted and the evaluation procedure.
Any one change to products authorised under national procedures in different Member States is therefore treated in a number of different ways in terms of the dossier to be submitted and the evaluation procedure.
This situation has some undesirable repercussions:
This situation has some undesirable repercussions:
– an unjustified additional administrative burden for the competent authorities and pharmaceutical businesses;
– an unjustified additional administrative burden for the competent authorities and pharmaceutical businesses;
– logistical issues for the actual implementation of changes;
– logistical issues for the actual implementation of changes;
– widely differing deadlines for introducing changes to the summary of characteristics of the product and the information leaflet for healthcare personnel and patients, with a knock-on effect on the overall working of the single market in pharmaceutical products;
– widely differing deadlines for introducing changes to the summary of characteristics of the product and the information leaflet for healthcare personnel and patients, with a knock-on effect on the overall working of the single market in pharmaceutical products;
– for patients, since the introduction of some changes that improve the effectiveness of a medicine may be delayed or never happen at all.
– for patients, since the introduction of some changes that improve the effectiveness of a medicine may be delayed or never happen at all.
(3) Planned improvements
(3) Planned improvements
The rapporteur actively supports the Commission’s proposal designed to revise and simplify the variations system for the benefit of human and animal health.
The rapporteur actively supports the Commission’s proposal designed to revise and simplify the variations system for the benefit of human and animal health.
It must be made possible for all medicinal products, whatever procedure was applied in authorising their marketing, to be subject to the same evaluation, approval and administrative-processing criteria in the event of changes being made to them.
It must be made possible for all medicinal products, whatever procedure was applied in authorising their marketing, to be subject to the same evaluation, approval and administrative-processing criteria in the event of changes being made to them.
An optimisation of the system will, inter alia, be of long-term benefit to patients, in that it will encourage improvement of medicines and have a favourable impact on the use of the competent authorities’ resources with a consequent improvement in public health protection.
An optimisation of the system will, inter alia, be of long-term benefit to patients, in that it will encourage improvement of medicines and have a favourable impact on the use of the competent authorities’ resources with a consequent improvement in public health protection.
Simplifying the process of changing the terms of marketing authorisations for medicinal products will mean they are subject to the same criteria with regard to the authorisation, administrative management and supervision of the changes made, whatever the legal procedure whereby the medicinal products were licensed may have been.
Simplifying the process of changing the terms of marketing authorisations for medicinal products will mean they are subject to the same criteria with regard to the authorisation, administrative management and supervision of the changes made, whatever the legal procedure whereby the medicinal products were licensed may have been.
For reasons of harmonisation and simplification, therefore, it is important that changes to marketing authorisations should be governed by the same regulatory requirements, whatever licensing procedure was initially used.
For reasons of harmonisation and simplification, therefore, it is important that changes to marketing authorisations should be governed by the same regulatory requirements, whatever licensing procedure was initially used.
This will bring benefits for all concerned: patients, authorities and pharmaceutical companies.
This will bring benefits for all concerned: patients, authorities and pharmaceutical companies.
Over and above this harmonisation of all medicinal products, it is also desirable to simplify the regulatory system for handling changes to marketing authorisations, particularly in the case of minor changes whose effects on the quality, safety and effectiveness of the medicine concerned are minimal or non-existent.
Over and above this harmonisation of all medicinal products, it is also desirable to simplify the regulatory system for handling changes to marketing authorisations, particularly in the case of minor changes whose effects on the quality, safety and effectiveness of the medicine concerned are minimal or non-existent.
The Commission Regulation concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products adopted unanimously on 10 June 2008 significantly simplifies the system.
The Commission Regulation concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products adopted unanimously on 10 June 2008 significantly simplifies the system.
In order to put in place an optimal regulatory system for managing changes to marketing authorisations, it is important to define precisely the different categories of change.
In order to put in place an optimal regulatory system for managing changes to marketing authorisations, it is important to define precisely the different categories of change.
The Commission provides for detailed lists to be drawn up for each category of change.
The Commission provides for detailed lists to be drawn up for each category of change.
It is important to capitalise on the experience acquired by the existing national systems.
It is important to capitalise on the experience acquired by the existing national systems.
In the case of changes relating to medicinal products licensed under national procedures, some Member States have already applied a simple notification system to a large number of changes that they regard as minor, following Germany’s example.
In the case of changes relating to medicinal products licensed under national procedures, some Member States have already applied a simple notification system to a large number of changes that they regard as minor, following Germany’s example.
These national lists of different types of change have been used as a basis for drawing up the European lists.
These national lists of different types of change have been used as a basis for drawing up the European lists.
The Commission proposes a number of significant improvements to the regulatory system for managing changes to marketing authorisations, also following the German example closely in the regulation.
The Commission proposes a number of significant improvements to the regulatory system for managing changes to marketing authorisations, also following the German example closely in the regulation.
For reasons of proportionality, homeopathic medicines and traditional herbal medicines which have not received a marketing authorisation, but are subject to a simplified registration procedure, continue to be excluded from the regulation’s scope.
For reasons of proportionality, homeopathic medicines and traditional herbal medicines which have not received a marketing authorisation, but are subject to a simplified registration procedure, continue to be excluded from the regulation’s scope.
The rapporteur welcomes this, because it avoids complicating a registration procedure which was simpler in some Member States.
The rapporteur welcomes this, because it avoids complicating a registration procedure which was simpler in some Member States.
Nonetheless, an additional improvement could be made to the system proposed in cases where a change relates to a number of marketing authorisations, with the possibility of a single submission covering all the marketing authorisations.
Nonetheless, an additional improvement could be made to the system proposed in cases where a change relates to a number of marketing authorisations, with the possibility of a single submission covering all the marketing authorisations.
In its regulation, the Commission proposes restricting this possibility to minor Type-IA changes.
In its regulation, the Commission proposes restricting this possibility to minor Type-IA changes.