http://www.legislation.gov.uk/eur/2012/528/article/95FRegulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (Text with EEA relevance)Regulation (EU) No 528/2012 of the European Parliament and of the CouncilRegulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (Text with EEA relevance)King's Printer of Acts of Parliamenthttps://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02012R0528-20191120texttext/xmlen2024-07-31Expert Participation2024-04-06 CHAPTER XVII<Strong>FINAL PROVISIONS</Strong><Addition ChangeId="key-b261474fd75e07ea6a720d53ff01224a-1721902390935" CommentaryRef="key-b261474fd75e07ea6a720d53ff01224a">Transitional measures for applications for same biocidal product authorisations</Addition>Article 95F1This Article applies where—aan application was made to the United Kingdom competent authority before IP completion day under Articles 3 or 4 of Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council, andba decision was not made before IP completion day.2The application is to be treated as having been made under Articles 3 or 4 (as appropriate) of Regulation (EU) No 414/2013 and the time limits under those Articles are apply from—athe date on which the applicant resubmits the application and any supporting data to the competent authority, orbwhere the applicant relies on a letter of access, whichever is the later of the following—ithe applicant resubmits the application, oriithe data owner resubmits the data.3Where the applicant does not meet the requirements of this Article, the application must be rejected by the competent authority and Article 89(11) applies as if the application had been submitted in accordance with Article 89(9).4For the purposes of this Article, data submitted by the applicant or the data owner must include relevant data for the reference product.5The resubmission of any application and data referred to in paragraph 2 must be completed in accordance with Article 71 of this Regulation and within 180 days of IP completion day.Arts. 95A-95N inserted (31.12.2020) by S.I. 2019/720, Sch. 4 para. 2 (as inserted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 4)
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<Addition ChangeId="key-b261474fd75e07ea6a720d53ff01224a-1721902390935" CommentaryRef="key-b261474fd75e07ea6a720d53ff01224a">The application is to be treated as having been made under Articles 3 or 4 (as appropriate) of Regulation (EU) No 414/2013 and the time limits under those Articles are apply from—</Addition>
</Text>
<P3 DocumentURI="http://www.legislation.gov.uk/eur/2012/528/article/95F/2/a" IdURI="http://www.legislation.gov.uk/id/eur/2012/528/article/95F/2/a" id="article-95F-2-a">
<Pnumber PuncBefore="(" PuncAfter=")">
<Addition ChangeId="key-b261474fd75e07ea6a720d53ff01224a-1721902390935" CommentaryRef="key-b261474fd75e07ea6a720d53ff01224a">a</Addition>
</Pnumber>
<P3para>
<Text>
<Addition ChangeId="key-b261474fd75e07ea6a720d53ff01224a-1721902390935" CommentaryRef="key-b261474fd75e07ea6a720d53ff01224a">the date on which the applicant resubmits the application and any supporting data to the competent authority, or</Addition>
</Text>
</P3para>
</P3>
<P3 DocumentURI="http://www.legislation.gov.uk/eur/2012/528/article/95F/2/b" IdURI="http://www.legislation.gov.uk/id/eur/2012/528/article/95F/2/b" id="article-95F-2-b">
<Pnumber PuncBefore="(" PuncAfter=")">
<Addition ChangeId="key-b261474fd75e07ea6a720d53ff01224a-1721902390935" CommentaryRef="key-b261474fd75e07ea6a720d53ff01224a">b</Addition>
</Pnumber>
<P3para>
<Text>
<Addition ChangeId="key-b261474fd75e07ea6a720d53ff01224a-1721902390935" CommentaryRef="key-b261474fd75e07ea6a720d53ff01224a">where the applicant relies on a letter of access, whichever is the later of the following—</Addition>
</Text>
<P4 DocumentURI="http://www.legislation.gov.uk/eur/2012/528/article/95F/2/b/i" IdURI="http://www.legislation.gov.uk/id/eur/2012/528/article/95F/2/b/i" id="article-95F-2-b-i">
<Pnumber PuncBefore="(" PuncAfter=")">
<Addition ChangeId="key-b261474fd75e07ea6a720d53ff01224a-1721902390935" CommentaryRef="key-b261474fd75e07ea6a720d53ff01224a">i</Addition>
</Pnumber>
<P4para>
<Text>
<Addition ChangeId="key-b261474fd75e07ea6a720d53ff01224a-1721902390935" CommentaryRef="key-b261474fd75e07ea6a720d53ff01224a">the applicant resubmits the application, or</Addition>
</Text>
</P4para>
</P4>
<P4 DocumentURI="http://www.legislation.gov.uk/eur/2012/528/article/95F/2/b/ii" IdURI="http://www.legislation.gov.uk/id/eur/2012/528/article/95F/2/b/ii" id="article-95F-2-b-ii">
<Pnumber PuncBefore="(" PuncAfter=")">
<Addition ChangeId="key-b261474fd75e07ea6a720d53ff01224a-1721902390935" CommentaryRef="key-b261474fd75e07ea6a720d53ff01224a">ii</Addition>
</Pnumber>
<P4para>
<Text>
<Addition ChangeId="key-b261474fd75e07ea6a720d53ff01224a-1721902390935" CommentaryRef="key-b261474fd75e07ea6a720d53ff01224a">the data owner resubmits the data.</Addition>
</Text>
</P4para>
</P4>
</P3para>
</P3>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/eur/2012/528/article/95F/3" IdURI="http://www.legislation.gov.uk/id/eur/2012/528/article/95F/3" id="article-95F-3">
<Pnumber PuncAfter=".">
<Addition ChangeId="key-b261474fd75e07ea6a720d53ff01224a-1721902390935" CommentaryRef="key-b261474fd75e07ea6a720d53ff01224a">3</Addition>
</Pnumber>
<P2para>
<Text>
<Addition ChangeId="key-b261474fd75e07ea6a720d53ff01224a-1721902390935" CommentaryRef="key-b261474fd75e07ea6a720d53ff01224a">Where the applicant does not meet the requirements of this Article, the application must be rejected by the competent authority and Article 89(11) applies as if the application had been submitted in accordance with Article 89(9).</Addition>
</Text>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/eur/2012/528/article/95F/4" IdURI="http://www.legislation.gov.uk/id/eur/2012/528/article/95F/4" id="article-95F-4">
<Pnumber PuncAfter=".">
<Addition ChangeId="key-b261474fd75e07ea6a720d53ff01224a-1721902390935" CommentaryRef="key-b261474fd75e07ea6a720d53ff01224a">4</Addition>
</Pnumber>
<P2para>
<Text>
<Addition ChangeId="key-b261474fd75e07ea6a720d53ff01224a-1721902390935" CommentaryRef="key-b261474fd75e07ea6a720d53ff01224a">For the purposes of this Article, data submitted by the applicant or the data owner must include relevant data for the reference product.</Addition>
</Text>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/eur/2012/528/article/95F/5" IdURI="http://www.legislation.gov.uk/id/eur/2012/528/article/95F/5" id="article-95F-5">
<Pnumber PuncAfter=".">
<Addition ChangeId="key-b261474fd75e07ea6a720d53ff01224a-1721902390935" CommentaryRef="key-b261474fd75e07ea6a720d53ff01224a">5</Addition>
</Pnumber>
<P2para>
<Text>
<Addition ChangeId="key-b261474fd75e07ea6a720d53ff01224a-1721902390935" CommentaryRef="key-b261474fd75e07ea6a720d53ff01224a">The resubmission of any application and data referred to in paragraph 2 must be completed in accordance with Article 71 of this Regulation and within 180 days of IP completion day.</Addition>
</Text>
</P2para>
</P2>
</P1para>
</P1>
</P1group>
</EUChapter>
</EUBody>
</EURetained>
<Commentaries>
<Commentary id="key-b261474fd75e07ea6a720d53ff01224a" Type="F">
<Para>
<Text>
<CitationSubRef id="ccd8e1202407251257318120100" URI="http://www.legislation.gov.uk/id/eur/2012/528/article/95A" UpTo="http://www.legislation.gov.uk/id/eur/2012/528/article/95N" Type="group" StartSectionRef="article-95A" EndSectionRef="article-95N">Arts. 95A-95N</CitationSubRef>
inserted (31.12.2020) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2019/720" id="d10e4" Class="UnitedKingdomStatutoryInstrument" Year="2019" Number="720">S.I. 2019/720</Citation>
,
<CitationSubRef CitationRef="d10e4" id="ccd8e7202407251257318120100" URI="http://www.legislation.gov.uk/id/uksi/2019/720/schedule/4/paragraph/2" Operative="true" SectionRef="schedule-4-paragraph-2">Sch. 4 para. 2</CitationSubRef>
(as inserted by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2020/1567" id="d10e10" Class="UnitedKingdomStatutoryInstrument" Year="2020" Number="1567" Title="The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020">The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567)</Citation>
,
<CitationSubRef CitationRef="d10e10" id="ccd8e13202407251257318120100" URI="http://www.legislation.gov.uk/id/uksi/2020/1567/regulation/1/2" SectionRef="regulation-1-2">reg. 1(2)</CitationSubRef>
,
<CitationSubRef CitationRef="d10e10" id="ccd8e16202407251257318120100" URI="http://www.legislation.gov.uk/id/uksi/2020/1567/schedule/4" Operative="true" SectionRef="schedule-4">Sch. 4</CitationSubRef>
)
</Text>
</Para>
</Commentary>
</Commentaries>
</Legislation>