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Results for tag Biocidal product authorisation

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../file-system/small/txt BPR - ABP - Union authorisation - links general Related List of product-types Similar conditions of use Comparative assessment CA documents on Biocidal product family concept Overview of Article 44 (5) requests Similar Results	16/04/24
../file-system/small/txt Understanding BPR - external links general See also Getting started with EU chemicals legislation European Commission - Biocides Biocidal Products Directive (Directive 98/8/EC) Biocides Relevant Document Links R4BP 3 user manuals Guidance... Similar Results	15/03/24
../file-system/small/txt Simplified authorisations - Submit your application general Authorisation of biocidal products Prepare your IUCLID dossier. Log into R4BP 3. From the ‘NEW APPLICATION' tab, select ‘SA-APP – National authorisation - simplified procedure'. The application... Similar Results	08/02/24
../file-system/small/txt Simplified authorisations toptext general Make sure that you have everything you need before making your application. The Biocides Submission Manual (BSM) ‘Application instructions: How to submit an application for Simplified... Similar Results	08/02/24
../file-system/small/txt Submit applications - Union Authorisations general Getting started – pre-submission Prepare your SPC file. Log into R4BP 3. From the ‘NEW APPLICATION' tab, select ‘UP-APP – Pre-submission for union authorisation' to launch the application ‘wizard',... Similar Results	08/02/24
../file-system/small/txt Technical equivalence and chemical similarity -toptext general Make sure that you have everything you need before making your application. The Biocides Submission Manual (BSM) ‘Application instructions: How to submit an application for Union Authorisation'.... Similar Results	08/02/24
../file-system/small/txt Submit applications - Notification for a product in a product family general Notification for a product in a product family Create your SPC file from the authorised SPC of the reference family asset. From the ‘ASSETS' tab, search for the relevant national authorisation... Similar Results	07/02/24
../file-system/small/txt Submit applications - IT-Tools general IT-Tools IUCLID R4BP 3 Similar Results	07/02/24
../file-system/small/txt Submit applications for national authorisation starters general Make sure that you have everything you need before making your application. The Biocides Submission Manual (BSM) ‘Application instructions: How to submit an application for National Authorisation... Similar Results	07/02/24
../file-system/small/txt BPR - ABP - simplified authorisation - links 2 general Regulations Biocidal Products Regulation - Annex I Regulation (EU) 528/2012 Similar Results	31/08/23
../file-system/small/txt Same biocidal products authorisation general To meet the needs of companies and reduce their administrative burdens, the Same Biocidal Products Regulation (Regulation 414/2013, amended by Regulation 2016/1802) introduces the possibility to... Similar Results	07/06/23
../file-system/small/txt BPR - National authorisation renewal general The Biocidal Product Regulation defines the renewal of a national authorisation as "an application by or on behalf of an authorisation holder wishing to seek the renewal of a national authorisation... Similar Results	01/06/23
../file-system/small/txt BPR - AS - dossier submission - links general Related Submit a dossier - R4BP 3 BPR Coordination Group Similar Results	01/06/23
../file-system/small/txt BPR - ABP - national authorisation and mutual recognition general National authorisation Companies planning to sell their products in one EU Member State must apply for product authorisation in that country. To do so, they submit an application for national... Similar Results	01/06/23
../file-system/small/txt Biocidal Products Regulation Active substance approval Biocidal Products Regulation Consolidated version of the Biocidal Products Regulation The consolidated version of the Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22... Similar Results	13/01/23
../file-system/small/txt Related Links BPR product family general Related Prepare a dossier – IUCLID Submit a dossier – R4BP 3 Biocides Submission Manuals CA documents on biocidal product families Practical Guides Similar Results	02/09/22
../file-system/small/txt BPR - ABP - simplified authorisation - links general Related Prepare a dossier - IUCLID Submit a dossier - R4BP 3 Guidance on Information Requirements Biocides Submission Manual Nanomaterials and the Biocidal Products Regulation Biocidal product... Similar Results	02/09/22
../file-system/small/txt Submit applications - FolloManuals and guidance general Manuals and guidance Biocides Submission Manuals Guidance on biocides legislation Practical Guides on BPR ECHA accounts and EU Login Q&A Supporting documents Similar Results	01/09/22
../file-system/small/txt natinal authorisation renewal - Mutual recognition evaluation process general Once the reference Member State Competent Authority (MSCA) has validated the application for the renewal of the national authorisation of a biocidal product (or a biocidal product family) granted... Similar Results	10/06/22
../file-system/small/txt Understanding BPR general The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles... Similar Results	08/06/22
../file-system/small/txt Authorisation of biocidal products general Related Bridging the endocrine disruptor assessment of biocidal non-active substances with REACH (agreed at 91st CA meeting) [PDF][EN] Guidelines for assessing confidentiality claims [EN][PDF]... Similar Results	12/04/22
../file-system/small/txt Biocidal products - need help general See a problem or have feedback? Similar Results	08/04/22
Authorisation of biocidal products family Instructions_biocidal_product_family_overview_v2_en.pdf (1.4 MBk) Biocidal product authorisation Authorisation of biocidal products family Similar Results	14/01/22
Authorisation of biocidal products family biocidal_product_family_overview_v2-1_en.xlsx (72 KBk) Biocidal product authorisation Authorisation of biocidal products family Similar Results	14/01/22
Proposal to bridge the endocrine disruptor assessment of biocidal non-active substances with REACH screening and assessment ca-march21-Doc43_final_bridging_biocides_with _reach_en.pdf (346 KBk) Biocidal product authorisation Proposal to bridge the endocrine disruptor assessment of biocidal non-active substances with REACH screening and assessment Similar Results	22/04/21
../file-system/small/txt Content pages - Subscribe Active substance approval Follow us Read ECHA Weekly news Subscribe to our news Similar Results	08/04/21
../file-system/small/txt Biocidal products - Further information Biocidal product authorisation Further information Authorisation of Biocidal Products Products types BPR Regulation Q&A Biocidal Products Regulation BPC opinions on Union authorisation Similar Results	15/04/19
../file-system/small/txt BPC sidebar - link Active substance approval About us Biocidal Products Committee Working groups Similar Results	15/04/19
../file-system/small/txt BPR - upcoming dadlines - footnotes Active substance approval * The comprehensive list of the applicable deadline for each of the compliant notification is given in List of notifications ** Article 3(2) RPR applications can only be made by the successful... Similar Results	11/04/19
../file-system/small/txt BPR-upcoming deadlines-toptext Active substance approval The following deadlines are listed to help companies to comply with their obligations under the Biocidal Products Regulation (BPR) and the Review Programme Regulation (RPR). AS = active substance... Similar Results	12/02/19
../file-system/small/txt Authorisation cancellation on request Biocidal product authorisation Authorisation cancellation on request Log into R4BP 3. From the ‘ASSETS’ tab, search for the specific asset number by filling in some search criterion. Clicking on the asset number hyperlink in the... Similar Results	23/11/18
../file-system/small/txt Submit applications - Classification of a change to a product authorisation Biocidal product authorisation Classification of a change to a product authorisation Log into R4BP 3. From the ‘NEW APPLICATION' tab, select ‘CC-APP – Classification of a change to a product authorisation' to launch the... Similar Results	23/11/18
../file-system/small/txt Submit applications - Mutual recognition in sequenceSubmit applications - Renewal of authorisation including authorisations subject to mutual recognition Biocidal product authorisation Renewal of authorisation(s) (including authorisations subject to mutual recognition) Log into R4BP 3. From the ‘ASSETS' tab, search for the relevant national authorisation asset you wish to renew.... Similar Results	23/11/18
../file-system/small/txt Submit applications - Mutual recognition in sequence Biocidal product authorisation Mutual recognition in sequence Draft your SPC file from the authorised SPC of the reference asset. Log into R4BP 3. You can launch your application in two different ways: From the ‘NEW APPLICATION'... Similar Results	23/11/18
../file-system/small/txt Submit applications - Mutual recognition in parallel Biocidal product authorisation Mutual recognition in parallel Draft your SPC file from the SPC of the reference case. Log into R4BP 3. You can launch your application in three different ways: During the submission of an... Similar Results	23/11/18
../file-system/small/txt Submit applications - Authorisation of biocidal products Biocidal product authorisation Authorisation of biocidal products Prepare your IUCLID dossier. From the ‘NEW APPLICATION' tab, select ‘NA-APP – Application for national authorisation' to launch the application ‘wizard', which... Similar Results	23/11/18
../file-system/small/txt Submit applications - Inquire to share data for a biocidal product Biocidal product authorisation Inquire to share data for a biocidal product Log into R4BP 3. From the ‘NEW APPLICATION' tab, select ‘IN-REB – Inquire to share data (for biocidal product)' and enter the reference number (the... Similar Results	23/11/18
../file-system/small/txt Submit applications - Parallel trade Biocidal product authorisation Parallel trade Log into R4BP 3. From the ‘NEW APPLICATION' tab, select ‘PP-APP – Parallel trade' and enter the reference numbers (the national authorisation asset number in the Member State of... Similar Results	23/11/18
../file-system/small/txt Submit applications - Notification of experiment or test Biocidal product authorisation Notification of experiment or test Prepare your IUCLID dossier. Log into R4BP 3. From the ‘NEW APPLICATION' tab, select ‘ET-NOT – Notification of experiment or test' to launch the application... Similar Results	23/11/18
../file-system/small/txt Submit applications - Notification of unexpected or adverse effect Biocidal product authorisation Notification of unexpected or adverse effect Log into R4BP 3. From the ‘ASSETS' tab, search for the relevant national authorisation asset for which you wish to notify unexpected or adverse effect..... Similar Results	23/11/18
../file-system/small/txt Submit applications - Transfer of authorisation Biocidal product authorisation Transfer of authorisation The owner of a national authorisation asset must first initiate a transfer process in R4BP 3, this is done in the ‘Delegation/ Nomination’ tab of the asset. Once the owner... Similar Results	23/11/18
../file-system/small/txt Submit applications - Merge of product authorisations in one product family Biocidal product authorisation Merge of product authorisation(s) in one product family Draft your SPC file from the authorised SPC of the reference asset. Log into R4BP 3. From the ‘NEW APPLICATION' tab, select ‘NA-MRG – Merge... Similar Results	23/11/18
../file-system/small/txt Submit applications - Administrative change on request Biocidal product authorisation Administrative change on request Draft your SPC file from the authorised SPC of the reference asset. Log into R4BP 3. From the ‘ASSETS' tab, search for the relevant national authorisation asset for... Similar Results	23/11/18
../file-system/small/txt Submit applications - Minor and major change on request Biocidal product authorisation Minor and major change on request Prepare your IUCLID dossier. Log into R4BP 3. From the ‘ASSETS' tab, search for the relevant national authorisation asset for which you wish to request a change.... Similar Results	23/11/18
../file-system/small/txt Authorisation of the same biocidal product - pending and authorised Biocidal product authorisation Authorisation of the same biocidal product (pending and authorised) Create your SPC file from the authorised SPC of the reference family case or asset, using specific functionality in the SPC... Similar Results	22/11/18
../file-system/small/txt Regulations - BPR - passed deadlines Active substance approval These deadlines in Biocidal Products Regulation (BPR) and the Review Programme Regulation (RPR) have passed. AS = active substance PT = product type AS/PT = active substance/ product-type... Similar Results	13/06/18
../file-system/small/txt BPR - research and development - related links Active substance approval Related R4BP 3 Similar Results	05/09/17
../file-system/small/txt Submit applications - Related links Active substance approval Related Appeals Data sharing ECHA Helpdesk National helpdesks Similar Results	10/08/17
../file-system/small/txt BPR - ABP - Union authorisation - evaluation process - links Biocidal product authorisation Related Guidance on Information Requirements Biocidal Product Committee Substitution criteria Similar Results	04/08/17
../file-system/small/txt Understanding BPR - related links Active substance approval Related Approval of active substances Authorisation of biocidal products Technical equivalence Active substance suppliers Data sharing Similar Results	03/08/17
../file-system/small/txt Simplified authorisations Follow up your applications Biocidal product authorisation Follow up your applications Important – make a note of your submission number. You will need it for further reference. Important - check your tasks and messages in R4BP 3 regularly. They can... Similar Results	14/06/17
../file-system/small/txt Union authorisations - Follow up your applications Biocidal product authorisation Follow up your applications Important – make a note of your submission number. You will need it for further reference. Important - check your tasks and messages in R4BP 3 regularly. They can... Similar Results	14/06/17
../file-system/small/txt National authorisation: Withdraw your application Biocidal product authorisation Withdraw your application If you don’t want to proceed with one of your application, you are allowed to withdraw it from the system: Search for your case In the case details page, click on... Similar Results	14/06/17
Notification of substances that benefitted from the derogation for food and feed notification_requirements_food_n_feed_en.pdf (188 KBk) Active substance approval Notification of substances that benefitted from the derogation for food and feed Similar Results	24/01/17
List of substances deadlines list_substances_deadline_en.pdf (260 KBk) Active substance approval List of substances deadlines Similar Results	24/01/17
../file-system/small/txt Evaluation process for national authorisation renewal Biocidal product authorisation Once the receiving MSCA has accepted the application for the renewal of the national authorisation of a biocidal product (or a biocidal product family), the evaluation process starts. This graphic... Similar Results	16/12/16
../file-system/small/txt BPR - Dossier submission for national authorisation renewal Biocidal product authorisation The national authorisation renewal applications, including those subject to or granted through mutual recognition, are submitted through R4BP 3. An IUCLID file may be required in certain conditions... Similar Results	16/12/16
../file-system/small/txt BPR - national authorisation and mutual recognition - links Biocidal product authorisation Regulations Biocidal Products Regulation Amendment to Commission Implementing Regulation specifying a procedure for the authorisation of same biocidal products Similar Results	02/11/16
../file-system/small/txt Authorisation of biocidal products Biocidal product authorisation All biocidal products must get an authorisation before they can be made available on the market. Companies can choose between several alternative processes, depending on their product and the... Similar Results	27/10/16
same_biocidal_product_graphic_en.png (19 KBk) Biocidal product authorisation Similar Results	27/10/16
../file-system/small/txt Product family regulations Biocidal product authorisation Regulations Biocidal Products Regulations Similar Results	27/07/16
../file-system/small/txt BPR - ABP - simplified authorisation procedure -links Biocidal product authorisation Related links List of approved active substances Prepare a dossier - IUCLID Submit a dossier - R4BP 3 Similar Results	21/07/16
In situ active substance/precursor-combination open for notification biocides_substances_redefined_identity_en.pdf (206 KBk) Active substance approval In situ active substance/precursor-combination open for notification Similar Results	19/01/16
../file-system/small/txt Authorisation of biocidal products link to authorised bp pages Biocidal product authorisation Information on Chemicals List of authorised biocidal products Similar Results	11/03/15
../file-system/small/txt Submit applications - Follow up your applications Biocidal product authorisation Follow up your applications Important – make a note of your submission number. You will need it for further reference. Important - check your tasks and messages in R4BP 3 regularly. They can... Similar Results	22/01/15
../file-system/small/txt Union auhorisations - support Biocidal product authorisation Support Small or Medium-sized Enterprises (SMEs) Supporting Documents page Similar Results	03/12/14
../file-system/small/txt Active substances Submit your application Heading Biocidal product authorisation Submit your application Similar Results	02/12/14
../file-system/small/txt Submit applications - Legislation Active substance approval Legislation Legislation Biocidal Products Regulation explained Commission Implementing Regulation (EU) No 564/2013 (Fee Regulation) Similar Results	02/12/14
../file-system/small/txt Submit applications subheading Biocidal product authorisation Submit your applications Similar Results	01/12/14
../file-system/small/txt BPR - AS - National authorisation and mutual recognition renewal - regulation link Biocidal product authorisation Regulations Biocidal Products Regulation Regulation (EU) 528/2012 Regulation No 492/2014 Similar Results	17/07/14
This graph shows an overview of the dossier submission process. national_authorisation_renewal_dossier_submission_en (6 KBk) Biocidal product authorisation This graph shows an overview of the dossier submission process. Similar Results	04/06/14
overview of the dossier evaluation process national_authorisation_renewal_dossier_evaluation_en (7 KBk) Biocidal product authorisation overview of the dossier evaluation process Similar Results	04/06/14
mutual_recognisition_dossier_submission_en_.png mutual_recognisition_dossier_submission_en_ (10 KBk) Biocidal product authorisation mutual_recognisition_dossier_submission_en_.png Similar Results	04/06/14
../file-system/small/txt BPR-research-development-content1 Active substance approval Any tests and experiments carried out for research and development purposes using unauthorised biocidal products and their (not approved) active substances must be recorded and may require... Similar Results	06/03/14
../file-system/small/txt BPR - ABP - Union authorisation - evaluation process - graph Biocidal product authorisation This graph shows an overview of the dossier evaluation process Similar Results	24/01/14
union_authorisation_evaluation .jpg union_authorisation_evaluation (115 KBk) Biocidal product authorisation union_authorisation_evaluation .jpg Similar Results	24/01/14
../file-system/small/txt BPR - ABP - simplified authorisation procedure - graph Biocidal product authorisation This graph shows an overview of the application procedure for simplified authorisation. Similar Results	25/11/13
../file-system/small/txt BPR - ABP - Union authorisation - dossier submission - graph Biocidal product authorisation This graph shows an overview of the dossier submission process. Similar Results	25/11/13
../file-system/small/txt BPR - ABP - product family Biocidal product authorisation A biocidal products family is a group of biocidal products that are used for similar purposes and contain active substances with same specifications. A biocidal product family also has specified... Similar Results	19/11/13
../file-system/small/txt BPR - ABP - simplified authorisation procedure Biocidal product authorisation Notification A biocidal product authorised according to the simplified authorisation procedure in one Member State can be placed on the market of other Member States without the need for mutual... Similar Results	19/11/13
../file-system/small/txt BPR - ABP - simplified authorisation procedure -steps Biocidal product authorisation Steps The process has several steps. Each step needs to be completed before the application can move to the next step. It is important that the applicant makes sure that all relevant deadlines are... Similar Results	19/11/13
../file-system/small/txt BPR - ABP -Simplified authorisation - application procedure Biocidal product authorisation The application procedure for simplified authorisation of a biocidal product is similar to the procedure for national product authorisation except for the different data requirements. Applicants... Similar Results	19/11/13
../file-system/small/txt BPR - AS - simplified authorisation procedure Biocidal product authorisation A simplified authorisation procedure aims to encourage the use of biocidal products that are less harmful for the environment, human and animal health. To be eligible for the simplified... Similar Results	19/11/13
../file-system/small/txt BPR - ABP - Union authorisation - evaluation process - actors Biocidal product authorisation Actors The main actors in the evaluation process are: Applicants Applicants are responsible for providing all necessary information in their dossiers. They should pay attention to the various... Similar Results	19/11/13
../file-system/small/txt BPR - ABP - Union authorisation - evaluation process - comparative Biocidal product authorisation Comparative assessment For those biocidal products containing one or more active substances that are candidates for substitution, the Biocidal Products Regulation foresees a comparative assessment... Similar Results	19/11/13
../file-system/small/txt BPR - ABP - Union authorisation - evaluation process - steps Biocidal product authorisation Steps If the evaluating competent authority considers that additional information is necessary to carry out the evaluation, it can request this from the applicant. The applicant has to provide the... Similar Results	19/11/13
../file-system/small/txt BPR - ABP - Union authorisation - evaluation process - overview Biocidal product authorisation Once the evaluating competent authority has validated the application for the Union authorisation of a biocidal product (or a biocidal product family), the evaluation process starts. The evaluating... Similar Results	19/11/13
../file-system/small/txt BPR - ABP - Union authorisation - dossier submission - overview Biocidal product authorisation Applications are submitted through R4BP 3 in the form of a IUCLID file. Similar Results	19/11/13
../file-system/small/txt BPR - ABP - Union authorisation - dossier submission - actors Biocidal product authorisation Actors The main actors in the dossier submission process are: Applicants Applicants are responsible for the quality of the data in their dossiers. They need to provide information about their... Similar Results	19/11/13
../file-system/small/txt BPR - ABP - Union authorisation - dossier submission - steps Biocidal product authorisation Steps Authorisation proceeds in several steps. Each step needs to be completed before the application can move to the next step. It is important that the applicant makes sure that all relevant... Similar Results	19/11/13
../file-system/small/txt BPR - ABP - Union authorisation Biocidal product authorisation The Biocidal Products Regulation (BPR) introduces the possibility to have certain biocidal products authorised at Union level. This will allow companies to place their biocidal products on the... Similar Results	19/11/13
simplied_authorisation.jpg simplied_authorisation (17 KBk) Biocidal product authorisation simplied_authorisation.jpg Similar Results	24/06/13
union_authorisation_submission .jpg union_authorisation_submission (14 KBk) Biocidal product authorisation union_authorisation_submission .jpg Similar Results	20/06/13
../file-system/small/txt BPR - ABP - Union authorisation - link about us Biocidal product authorisation About us Biocidal Products Committee Similar Results	20/06/13
six_lg.png six_lg (3 KBk) Active substance approval six_lg.png Similar Results	10/06/13
seven_lg.png seven_lg (3 KBk) Active substance approval seven_lg.png Similar Results	10/06/13
two_lg.png two_lg (4 KBk) Active substance approval two_lg.png Similar Results	11/09/12
three_lg.png three_lg (4 KBk) Active substance approval three_lg.png Similar Results	11/09/12
one_lg.png one_lg (3 KBk) Active substance approval one_lg.png Similar Results	11/09/12
four_lg.png four_lg (4 KBk) Active substance approval four_lg.png Similar Results	11/09/12

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