S T A T U T O R Y  I N S T R U M E N T S  
2020 No. 1471 
EXITING THE EUROPEAN UNION 
PATENTS 
The Supplementary Protection Certificates (Amendmen t) (EU 
Exit) Regulations 2020 
Made  - - - - 7th December 2020 
Coming into force in accordance with regulation 1(2 ) 
The Secretary of State makes these Regulations in e xercise of the powers conferred by section 
8C(1)( a) of the European Union (Withdrawal) Act 2018( b). 
In accordance with paragraph 8F(1) of Part 1A of Sc hedule 7( c) to the European Union 
(Withdrawal) Act 2018, a draft of this instrument h as been laid before Parliament and approved by 
resolution of each House of Parliament. 
Citation and commencement 
1. —(1) These Regulations may be cited as the Suppleme ntary Protection Certificates 
(Amendment) (EU Exit) Regulations 2020. 
(2)  This regulation and regulations 2 and 3 come into f orce immediately before IP completion 
day and regulations 4 to 7 come into force on IP co mpletion day. 
Amendments to the Patents (Amendment) (EU Exit) Reg ulations 2019 
2. —(1) Part 6 of the Patents (Amendment) (EU Exit) Re gulations 2019( d) (supplementary 
protection certificates for plant protection produc ts – amendments to Regulation (EC) No 
1610/96) is amended as follows. 
(2)  In the following paragraphs, a reference to an Arti cle or a paragraph is to that of Regulation 
(EC) 1610/96( e) and a reference to a regulation is to a regulatio n of the Patents (Amendment) (EU 
Exit) Regulations 2019. 
(3)  In Article 1 (definitions), as amended by regulatio n 20(3), omit paragraph 15. 
(4)  In Article 2(b) (scope), as inserted by regulation 22, for “UK”, substitute “GB or NI”. 
(5)  In Article 3(1) (conditions for obtaining a certifi cate), as amended by regulation 23— 
                                                                                                                                            
(a) Section 8C was inserted by section 21 of the Euro pean Union (Withdrawal Agreement) Act 2020 c. 1. 
(b) 2018 c. 16 as amended by the European Union (With drawal Agreement) Act 2020 c. 1. 
(c) Paragraph 8F of Part 1A of Schedule 7 was inserte d by section 41(4) of, and paragraph 5 of Schedule 5 to, the European 
Union (Withdrawal Agreement) Act 2020 c. 1. 
(d) S.I. 2019/801, as amended by S.I. 2020/1050. 
(e) EUR 1996/1610, as amended by S.I. 2019/801 and S. I. 2020/1050.  This is a reference to the retained version of Regulation 
(EC) 1610/96. That retained version is online at ht tp://www.legislation.gov.uk/eur/1996/1610/contents  2(a)  in sub-paragraph (b), for “UK”, substitute “GB or N I”; 
(b)  in sub-paragraph (d)— 
(i)  omit “UK”; 
(ii)  insert at the end “in the territory of England and Wales and Scotland or the territory 
of Northern Ireland as the case may be”. 
(6)  In Article 8 (content of the application for a cert ificate), as amended by regulation 24(2)— 
(a)  in paragraph 1(a)(iv)— 
(i)  for “UK authorization”, substitute “GB or NI author isation or both GB and NI 
authorisations”; 
(ii)  after “3(1)(b)”, insert “and (d)”; 
(b)  in paragraph (1)(a)(v)— 
(i)  for “UK”, substitute “GB or NI”; 
(ii)  after “authorization”, in the second place it occur s, insert “as referred to in Article 
3(1)(b) and (d)”. 
(7)  In Article 8, as amended by regulation 24(3)— 
(a)  in paragraph (b)— 
(i)  for “UK authorization”, substitute “GB or NI author isation or both GB and NI 
authorisations”; 
(ii)  after “3(1)(b)”, insert “and (d)”; 
(b)  in paragraph (c)— 
(i)  for “UK”, substitute “GB or NI ”; 
(ii)  after “3(1)(b)”, insert “and (d)”. 
(8)  In Article 9 (lodging of an application for a certi ficate), as amended by regulation 25(4)— 
(a)  for paragraph 2(d), substitute— 
“(d) the number and date of the GB or NI authorisat ion or both a GB and a NI 
authorisation provided under Article 8(1)(b), the p roduct identified in the 
authorisation and the territory in respect of which  the authorisation has been 
granted or has effect as if granted”; 
(b)  in paragraph (e), for “the UK authorisation”, subst itute “any GB or NI authorisation 
provided under Article 8(1)(b)”. 
(9)  In Article 10 (grant of the certificate or rejectio n of the application), as amended by 
regulation 26, omit paragraph 6. 
(10)  In regulation 27(3), omit sub-paragraph (a) of that  regulation. 
(11)  In Article 11(1)(e), as amended by regulation 27(3) , for “the UK authorization”, substitute 
“any authorisation provided under Article 8(1)(b)”.  
(12)  In Article 14(1) (expiry of the certificate), as am ended by regulation 30— 
(a)  at the end of paragraph (c), insert “or”; 
(b)  in paragraph (d), for “the appropriate authorizatio n or” substitute “all”. 
(13)  In regulation 30, omit paragraph 4 of that regulati on. 
3. —(1) Part 8 of the Patents (Amendment) EU Exit Regu lations 2019 (supplementary protection 
certificates for medicinal products – amendments to  Regulation (EC) No 469/2009) is amended as 
follows.  3(2)  In the following paragraphs, a reference to an Arti cle or a paragraph is to that of Regulation 
(EC) 469/2009( a) and a reference to a regulation is to a regulatio n of the Patents (Amendment) 
(EU Exit) Regulations 2019. 
(3)  In Article 1, in the definition of “UK authorisatio n” in paragraph (j) inserted by regulation 
52(3), after “market”, insert “in the United Kingdo m”.   
(4)  In Article 2 (scope), in paragraph (b), as inserted  by regulation 54, after “UK”, insert “, GB 
or NI”. 
(5)  In Article 3 (conditions for obtaining a certificat e), as inserted by regulation 54— 
(a)  in sub-paragraph (b), after “UK”, insert “, GB or N I”; 
(b)  in sub-paragraph (d)— 
(i)  after “UK”, insert “, GB or NI”; 
(ii)  insert at the end “in the territory of the United K ingdom, the territory of England and 
Wales and Scotland or the territory of Northern Ire land as the case may be”. 
(6)  In Article 8 (content of the application for a cert ificate), as amended by regulation 55(2)— 
(a)  for paragraph 1(a)(iv), substitute— 
 “(iv) the number and date of the UK, GB or NI auth orisation, or where there is 
more than one such authorisation, of each authorisa tion as referred to in 
Article 3(b) and (d);”; 
(b)  in paragraph (1)(a)(v)— 
(i)  after “UK”, insert “, GB or NI”; 
(ii)  after “authorisation”, in the second place it occur s, insert “as referred to in Article 
3(b) and (d)”. 
(7)  In Article 8(1), as amended by regulation 55(3)— 
(a)  in paragraph (b)— 
(i)  after “UK”, insert “, GB or NI authorisation or, wh ere there is more than one such 
authorisation, of each”; 
(ii)  after “3(b)” insert “and (d)”; 
(b)  in paragraph (c)— 
(i)  after “UK”, insert “, GB or NI”; 
(ii)  after “3(b)” insert “and (d)”. 
(8)  In Article 9 (lodging of an application for a certi ficate), as amended by regulation 56(4)— 
(a)  for paragraph 2(d), substitute— 
“(d) the number and date of the UK, GB or NI author isation or, where there is more 
than one such authorisation, each authorisation pro vided under Article 8(1)(b), the 
product identified in the authorisation or each aut horisation and the territory in 
respect of which the authorisation has been granted  or has effect as if granted”; 
(b)  in paragraph (e), for “the UK authorisation”, subst itute “any UK, GB or NI authorisation 
provided under Article 8(1)(b)”. 
(9)  In Article 10 (grant of the certificate or rejectio n of the application for a certificate) as 
amended by regulation 57, omit paragraph 7. 
(10)  In Article 11 (publication), as amended by regulati on 58(3)— 
(a)  for paragraph (d), insert— 
“(d) the number and date of the UK, GB or NI author isation or, where there is more 
than one such authorisation, of each authorisation provided under Article 8(1)(b) 
                                                                                                                                            
(a) EUR 2009/469, as amended by S.I. 2019/801 and S.I . 2020/1050. This is a reference to the retained ve rsion of Regulation 
EUR 2009/469. That retained version is online at ht tp://www.legislation.gov.uk/eur/2009/469/contents  4or Article 13A(1), the product identified in the au thorisation and the territory in 
respect of which the authorisation has been granted  or has effect as if granted;”; 
(b)  in paragraph (e), for “the UK authorisation”, subst itute “any UK, GB or NI authorisation 
provided under Article 8(1)(b)”. 
(11)  In Article 14(1) (expiry of the certificate), as am ended by regulation 61— 
(a)  at the end of sub-paragraph (c), insert “or”; 
(b)  in sub-paragraph (d), for “the appropriate authoris ation or” substitute “all UK, GB and 
NI”. 
(12)  In regulation 61, omit paragraph (4) of that regula tion.  
Amendments to Regulation (EC) 1610/96 
4.  Regulation (EC) 1610/96 of the European Parliament  and of the Council of 23 July 1996 
concerning the creation of a supplementary protecti on certificate for plant protection products is 
amended as set out in Part 1 of the Schedule. 
Amendments to Regulation (EC) 469/2009 
5.  Regulation (EC) 469/2009 of the European Parliamen t and of the Council of 6th May 2009 
concerning the supplementary protection certificate  for medicinal products is amended as set out 
in Part 2 of the Schedule. 
Amendment to the Patents Rules 2007 
6.  In the Patents Rules 2007( a), in rule 116A, as inserted by regulation 42 of th e Intellectual 
Property (Amendment etc.) (EU Exit) Regulations 202 0(b)— 
(a)  the existing text is numbered as paragraph 1; 
(b)  after paragraph 1, insert— 
“(2) Notifications under Article 13A of Regulation (EC) 1610/96 and Article 13A of 
Regulation (EC) 469/2009 must be made on Patents Fo rm SP6.”. 
Transitional provisions 
7. —(1) Where an application for an authorisation is m ade before IP completion day under— 
(a)  Directive 2001/83/EC( c) of the European Parliament and of the Council of 6 November 
2001 on the Community code relating to medicinal pr oducts for human use, 
(b)  Directive 2001/82/EC( d) of the European Parliament and of the Council of 6 November 
2001 on the Community code relating to veterinary m edicinal products, or 
(c)  Regulation (EC) No 1107/2009( e) of the European Parliament and of the Council of 21 
October 2009 concerning the placing of plant protec tion products on the market, 
but the authorisation is not granted until on or af ter IP completion day, these Regulations apply to 
any application for a supplementary protection cert ificate made in respect of the authorisation. 
(2)  These Regulations apply to an application for a sup plementary protection certificate made on 
or after IP completion day in respect of a UK autho risation granted or having effect as if granted 
before IP completion day. 
                                                                                                                                            
(a) S.I. 2007/3291, as by S.I. 2011/2052; there are o ther amending instruments but none are relevant. 
(b) S.I. 2020/1050. 
(c) OJ L311, 28.11.2001, p.67. 
(d) OJ L311, 28.11.2001, p.1. 
(e) OJ L309, 24.11.2009, p.1.  5(3)  The former regulations continue to apply to an appl ication for a supplementary protection 
certificate made, but not determined, before IP com pletion day in respect of a UK authorisation 
granted or having effect as if granted before IP co mpletion day. 
(4)  Where on or after IP completion day a UK authorisat ion granted or having effect before IP 
completion day is withdrawn and replaced with a GB authorisation and a NI authorisation, any 
certificate granted in respect of the UK authorisat ion does not lapse. 
(5)  For the purposes of paragraphs (2), (3) and (4), “U K authorisation” means an authorisation 
granted or having effect as if granted under— 
(a)  Directive 2001/83/EC of the European Parliament and  of the Council of 6 November 
2001 on the Community code relating to medicinal pr oducts for human use, 
(b)  Directive 2001/82/EC of the European Parliament and  of the Council of 6 November 
2001 on the Community code relating to veterinary m edicinal products, or 
(c)  Regulation (EC) No 1107/2009 of the European Parlia ment and of the Council of 21 
October 2009 concerning the placing of plant protec tion products on the market, 
and references to a UK, GB or NI authorisation, whe re they occur in these Regulations (but not 
including this regulation) are to be treated as mea ning a “UK authorisation” as defined in this 
paragraph. 
(6)  For the purposes of paragraphs (4) and (7)— 
(a)  “GB authorisation” has the meaning ascribed to it i n paragraph 15 of Article 1 of 
Regulation (EC) 1610/96, as amended by regulation 4  of, and paragraph 2 of the 
Schedule to, these Regulations, and paragraph (ja) of Article 1 of Regulation (EC) 
469/2009 as amended by regulation 5 of, and paragra ph 9 of the Schedule to, these 
Regulations; and 
(b)  “NI authorisation” has the meaning ascribed to it i n paragraph 16 of Article 1 of 
Regulation (EC) 1610/96, as amended by regulation 4  of, and paragraph 2 of the 
Schedule to, these Regulations and paragraph (jb) o f Article 1 of Regulation (EC) 
469/2009 as amended by regulation 5 of, and paragra ph 9 of the Schedule to, these 
Regulations. 
(7)  For the purposes of paragraph (4), where the former  regulations apply to a “UK 
authorisation” as defined in paragraph (5), the UK authorisation includes a GB authorisation and 
NI authorisation in combination. 
(8)  For the purposes of this regulation, “former regula tions” means Regulation (EC) 1610/96 
and Regulation (EC) 469/2009 without the amendments  made by these Regulations but including 
the amendments made by the Patents (Amendment) (EU Exit) Regulations 2019 and the 
Intellectual Property (Amendment etc.) (EU Exit Reg ulations) 2020. 
 
 
 
 
 Amanda Solloway 
 Parliamentary Under Secretary 
7th December 2020 Department for Business, Energy a nd Industrial Strategy 
 
 
 
  6 SCHEDULE Regulations 4 and 5 
Amendments to Regulations on Supplementary Protecti on Certificates 
PART 1 
Amendments to Regulation (EC) 1610/96 
Interpretation of Part 1 
1.  In this Part, a reference to an Article or a parag raph is to that of Regulation (EC) 1610/96. 
Article 1: definitions 
2.  In Article 1, after the definition of “patent” in paragraph 14, as inserted by regulation 20(3) of 
the Patents (Amendment) (EU Exit) Regulations 2019,  insert— 
“15.  “GB authorisation” means an authorisation, to plac e a plant protection product on the 
market in England and Wales and Scotland, granted o r having effect as if granted under 
Regulation (EC) 1107/2009( a); 
16.  “NI authorisation” means an authorisation, to plac e a plant protection product on the 
market in Northern Ireland, granted or having effec t as if granted in accordance with 
Regulation (EC) 1107/2009 as it has effect by virtu e of the Protocol on Ireland/Northern 
Ireland in the EU withdrawal agreement; 
17.  “prescribed” means prescribed by rules under secti on 123 of the Patents Act 1977.”. 
Article 4: subject matter of protection 
3.  In Article 4— 
(a)  for “authorizations”, substitute “GB or NI authoris ation or both GB and NI 
authorisations”; 
(b)  after “authorized”, insert “in the United Kingdom”.  
Article 5: effects of the certificate 
4.  In Article 5— 
(a)  the existing text is numbered as paragraph 1; 
(b)  in paragraph 1, after “Article 4”, insert “and para graphs 2 and 3”; 
(c)  after paragraph 1, insert— 
“2.  The protection conferred by a certificate in accor dance with paragraph 1 shall extend 
only to the territory in respect of which a valid G B or NI authorisation has been issued and 
the authorisation— 
(a) is the first authorisation for the product in t he territory in accordance with Article 
3(1)(b) and (d), and 
(b) has been issued before the certificate takes ef fect in accordance with Article 13(1). 
3. Where after the submission of an application for a certificate in accordance with 
Article 7 and before the certificate takes effect i n accordance with Article 13(1), a GB or NI 
authorisation is granted in respect of the same pro duct and the authorisation would have 
                                                                                                                                            
(a) EUR 2009/1107. This is a reference to the retaine d version of Regulation (EC) 2009/1107. That retain ed version is online at 
http://www.legislation.gov.uk/eur/2009/1107/content s.  7met the requirements of Article 3(b) and (d) had it  been granted on the date of submission 
of the application, the protection conferred by a c ertificate in accordance with paragraph 1 
shall extend to the territory of England and Wales and Scotland or the territory of Northern 
Ireland as the case may be.”. 
Article 7: application for a certificate 
5.  In Article 7, paragraph (1)— 
(a)  before “authorization”, insert “GB or NI”; 
(b)  after “3(1)(b)”, insert “and (d)”; 
(c)  after the end of the sentence, insert— 
“Where more than one such authorisation is granted before the application for a certificate 
is lodged, the application shall be lodged within s ix months of the date of grant of the 
earliest of such authorisations.”. 
Article 11: publication 
6.  In Article 11, for paragraph (d), substitute— 
“(d) the number and date of the UK, GB or NI author isation or, where there is more 
than one such authorisation, of each authorisation provided under Article 8(1)(b) 
or Article 13A(1), the product identified in the au thorisation and the territory in 
respect of which the authorisation has been granted  or has effect as if granted;”. 
Article 13A: authorisation granted after submission  of an application for a certificate 
7.  After Article 13, insert— 
“Article 13A 
Authorisation granted after submission of an applic ation for a certificate 
1.  Where after the submission of an application under  Article 7(1), but before the grant of 
a certificate under Article 10(1) in relation to a GB authorisation, a valid NI authorisation is 
granted which, at its date of grant, is the first a uthorisation to place the product on the 
market as a plant protection product in the territo ry of Northern Ireland, the applicant shall 
notify the comptroller of the grant of the NI autho risation, within six months of its date of 
grant and before the certificate takes effect under  Article 13(1), and provide the details set 
out in Article 8(1)(a)(iv) and (b) on the prescribe d form. 
2. Where after the submission of an application under  Article 7(1), but before the grant of 
a certificate under Article 10(1) in relation to a NI authorisation, a valid GB authorisation is 
granted which, at its date of grant, is the first a uthorisation to place the product on the 
market as a plant protection product in the territo ry of England and Wales and Scotland, the 
applicant shall notify the comptroller of the grant  of the GB authorisation, within six 
months of its date of grant and before the certific ate takes effect under Article 13(1), and 
provide the details set out in Article 8(1)(a)(iv) and (b) on the prescribed form. 
3. Where after the grant of a certificate under Artic le 10(1) in relation to a GB 
authorisation, but before expiry of the basic paten t, a valid NI authorisation is granted 
which, at its date of grant, is the first authorisa tion to place the product on the market as a 
plant protection product in the territory of Northe rn Ireland, the certificate holder shall 
notify the comptroller of the NI authorisation, wit hin six months of its date of grant and 
before the certificate takes effect under Article 1 3(1), and provide the details set out in 
Article 8(1)(a)(iv) and (b) on the prescribed form.  
4. Where after the grant of a certificate under Articl e 10(1) in relation to a NI 
authorisation, but before expiry of the basic paten t, a valid GB authorisation is granted 
which, at its date of grant, is the first authorisa tion to place the product on the market as a 
plant protection product in the territory of Englan d and Wales and Scotland, the certificate  8holder shall notify the comptroller of the grant of  the GB authorisation, within six months 
of its date of grant and before the certificate tak es effect under Article 13(1), and provide 
the details set out in Article 8(1)(a)(iv) and (b) on the prescribed form. 
5. If the applicant or certificate holder fails to no tify the comptroller of the grant of an 
authorisation in accordance with any of paragraphs 1 to 4, the protection conferred by a 
certificate granted under Article 10(1) shall not e xtend to any additional territory covered 
by that authorisation. 
6. On receipt of a notification under any of paragrap hs 1 to 4, the comptroller shall 
publish: 
(a) the number and date of the authorisation, 
(b) the product identified in that authorisation, a nd 
(c) the relevant territory in respect of which the authorisation has been granted or has 
effect as if granted.”. 
Article 14: expiry of the certificate 
8.  In Article 14, after paragraph 1, insert— 
“2.  Where a UK authorisation is withdrawn and replaced  simultaneously with a GB 
authorisation and a NI authorisation, the certifica te granted in respect of the UK 
authorisation shall not lapse. 
3. Where a UK, GB or NI authorisation is withdrawn, bu t one or more such authorisations 
remain valid, the protection conferred by the certi ficate shall, as from the date of 
withdrawal, no longer extend to the territory cover ed by the authorisation withdrawn but 
shall continue in respect of the territory covered by any remaining authorisation. 
4. For the purposes of paragraphs 2 and 3, “UK authori sation” means an authorisation to 
place a plant protection product on the market in t he United Kingdom, granted or having 
effect as if granted, prior to IP completion day, u nder Regulation (EC) 1107/2009( a) of the 
European Parliament and of the Council of 21 Octobe r 2009 concerning the placing of plant 
protection products on the market.”. 
Article 16: notification of lapse or invalidity 
9.  In Article 16— 
(a)  after “Article 14”, insert “(1)”; 
(b)  after “Article 15,” insert “or if the territorial e xtent of the certificate is limited in 
accordance with Article 14(3),”. 
PART 2 
Amendments to Regulation (EC) 469/2009 
Interpretation of Part 2 
10.  In this Part, a reference to an Article or a parag raph is to that of Regulation (EC) 469/2009. 
Article 1: definitions 
11.  In Article 1— 
                                                                                                                                            
(a) OJ L309, 24.11.2009, p.1.  9(a)  after the definition of “UK authorisation” in parag raph (j), as inserted by regulation 52(3) 
of the Patents (Amendment) (EU Exit) Regulations 20 19 and amended by regulation 3(3) 
of these Regulations, insert— 
“(ja) “GB authorisation” means, in relation to a pr oduct, an authorisation to place that 
product on the market in England and Wales and Scot land as a medicinal product 
granted or having effect as if granted in accordanc e with— 
 (i) Part 5 of the Human Medicines Regulations 2012 (a); or 
 (ii) regulation 4(3) of, and Schedule 1 to, the Ve terinary Medicines Regulations 
2013( b) as they have effect in England and Wales and Scot land; 
(jb) “NI authorisation” means, in relation to a pro duct, an authorisation to place that 
product on the market in Northern Ireland as a medi cinal product granted or having 
effect as if granted in accordance with Directive 2 001/83/EC or Directive 
2001/82/EC as they have effect by virtue of the Pro tocol on Ireland/Northern 
Ireland in the EU withdrawal agreement;”; 
(b)  After paragraph (k), insert— 
“(l) “prescribed” means prescribed by rules under s ection 123 of the Patents Act 
1977( c).”. 
Article 4: subject matter of protection 
12.  In Article 4— 
(a)  before “authorisation”, insert “UK, GB or NI”; 
(b)  after “authorised”, insert “in the United Kingdom”.  
Article 5: effects of the certificate 
13.  In Article 5— 
(a)  In paragraph 1, after “Article 4”, insert “and para graphs 1a and 1b”; 
(b)  after paragraph 1, insert— 
“1a.  The protection conferred by a certificate in accor dance with paragraph 1 shall extend 
only to the territory in respect of which a valid, UK, GB or NI authorisation has been issued 
and where the authorisation— 
(a) is the first authorisation for the product in t he territory in accordance with Article 
3(b) and (d), and 
(b) has been issued before the certificate takes ef fect in accordance with Article 13(1). 
1b.  Where after the submission of an application for a  certificate in accordance with 
Article 7(1) or (2) and before the certificate take s effect in accordance with Article 13(1), a 
GB or NI authorisation is granted in respect of the  same product and the authorisation 
would have met the requirements of Article 3(b) and  (d) had it been granted on the date of 
submission of the application, the protection confe rred by a certificate in accordance with 
paragraph 1 shall extend to the territory of Englan d and Wales and Scotland or the territory 
of Northern Ireland as the case may be.”; 
(c)  in paragraph 6— 
(i)  insert “prescribed” before “form”; 
(ii)  omit the words from “for” to the end. 
                                                                                                                                            
(a) S.I. 2012/1916. Regulation 58A is inserted by S.I . 2019/775, reg. 64. 
(b) S.I. 2013/2033. 
(c) 1977 c. 37; section 123 was last amended by the P atents Act 2004 c. 16.  10 Article 7: application for a certificate 
14.  In Article 7, paragraph (1)— 
(a)  before “authorisation”, insert “UK, GB or NI”; 
(b)  after “3(b)”, insert “and (d)”; 
(c)  after the end of the sentence, insert— 
“Where more than one such authorisation is granted before the application for a certificate 
is lodged, the application shall be lodged within s ix months of the date of grant of the 
earliest of such authorisations.”. 
Article 8: content of the application for a certifi cate 
15.  In Article 8— 
(a)  in paragraph 1(a)(ii), for “he”, substitute “the ap plicant”; 
(b)  in paragraph 1(d), after sub-paragraph (i), insert—  
 “(ii) details of the territory in respect of which  the statement referred to in sub-
paragraph (i) has been made.”. 
Article 9: lodging of an application for a certific ate 
16.  In Article 9, paragraph 2, after sub-paragraph (f) , insert— 
“(g) where an indication is given in accordance wit h sub-paragraph (f), details of the 
territory in respect of which an extension has been  applied for.”. 
Article 11: publication 
17.  In Article 11, after paragraph 3, insert— 
“3a.  Where notification is made that an extension of th e duration of a certificate has been 
granted, the notification shall specify the territo ry in respect of which the extension has 
been granted.”. 
Article 13: duration of the certificate 
18.  In Article 13, after paragraph 4 insert— 
“5.  An extension of the duration of a certificate in a ccordance with paragraph 3 in respect 
of— 
(a) a UK authorisation shall apply in the United Ki ngdom, 
(b) a GB authorisation shall apply in only England and Wales and Scotland, and 
(c) a NI authorisation shall apply in Northern Irel and only, 
on condition that the territorial protection confer red by the extension does not exceed that 
conferred by the certificate.”. 
Article 13A: authorisation granted after submission  of an application for a certificate 
19.  After Article 13, insert— 
“Article 13A  
Authorisation granted after submission of an applic ation for a certificate 
1.  Where after the date of submission of an applicati on under Article 7(1) or (2), but 
before the grant of a certificate under Article 10( 1) in relation to a NI authorisation, a valid 
UK or GB authorisation is granted which, at its dat e of grant, is the first authorisation to 
place the product on the market as a medicinal prod uct in the territory of the United  11 Kingdom or the territory of England and Wales and S cotland as the case may be, the 
applicant shall notify the comptroller of the grant  of the authorisation, within six months of 
its date of grant and before the certificate takes effect under Article 13(1), and provide the 
details set out in Article 8(1)(a)(iv) and (b) on t he prescribed form. 
2. Where after the submission of an application under  Article 7(1) or (2), but before the 
grant of a certificate under Article 10(1) in relat ion to a UK or GB authorisation, a valid NI 
authorisation is granted which, at its date of gran t, is the first authorisation to place the 
product on the market as a medicinal product in the  territory of Northern Ireland, the 
applicant shall notify the comptroller of the grant  of the authorisation, within six months of 
its date of grant and before the certificate takes effect under Article 13(1), and provide the 
details set out in Article 8(1)(a)(iv) and (b) on t he prescribed form. 
3. Where after the grant of a certificate under Artic le 10(1) in relation to a UK or GB 
authorisation, but before expiry of the basic paten t, a valid NI authorisation is granted 
which, at its date of grant, is the first authorisa tion to place the product on the market as a 
medicinal product in the territory of Northern Irel and, the certificate holder shall notify the 
comptroller of the grant of the authorisation, with in six months of its date of grant and 
before the certificate takes effect under Article 1 3(1), and provide the details set out in 
Article 8(1)(a)(iv) and (b) on the prescribed form.  
4.  Where after the grant of a certificate under Artic le 10(1) in relation to a NI 
authorisation, but before expiry of the basic paten t, a valid UK or GB authorisation is 
granted which, at its date of grant, is the first a uthorisation to place the product on the 
market as a medicinal product in the territory of t he United Kingdom or the territory of 
England and Wales and Scotland as the case may be, the certificate holder shall notify the 
comptroller of the grant of the NI authorisation, w ithin six months of its date of grant and 
before the certificate takes effect under Article 1 3(1), and provide the details set out in 
Article 8(1)(a)(iv) and (b) on the prescribed form.  
5. If the applicant or the certificate holder fails t o notify the comptroller of the grant of an 
authorisation in accordance with paragraph 1, 2, 3 or 4 the protection conferred by a 
certificate granted under Article 10 shall not exte nd to any additional territory covered by 
that authorisation. 
6. On receipt of a notification under any of paragrap hs 1 to 4, the comptroller shall 
publish: 
(a) the number and date of the authorisation, 
(b) the product identified in that authorisation, a nd 
(c) the territory in respect of which the authorisa tion has been granted or has effect as 
if granted. 
 
Article 13B 
Extension of the duration of a certificate  
1.  Where after an application for an extension of the  duration of a certificate in 
accordance with Article 7(3) or (4) has been made i n respect of a GB authorisation, but 
before the application is granted, an application i s also made for an extension of the 
duration of the certificate in respect of a NI auth orisation in accordance with Article 7(3) or 
(4), the duration of the certificate, if the extens ion is granted, shall be extended in 
accordance with Article 13(3) and (5) to include th e territory of Northern Ireland. 
2.  Where after an application for an extension of the  duration of a certificate in 
accordance with Article 7(3) or (4) has been made i n respect of a NI authorisation, but 
before the application is granted, an application i s also made for an extension of the 
duration of the certificate in respect of a GB auth orisation in accordance with Article 7(3) 
or (4), the duration of the certificate shall be ex tended in accordance with Article 13(3) and 
(5) to include the territory of England and Wales a nd Scotland.  12 3.  Where after the grant in accordance with Article 1 0(6) of an application for an 
extension of the duration of a certificate in respe ct of a GB authorisation, an application is 
made, in accordance with Article 7(4), for an exten sion of the certificate in respect of a NI 
authorisation, the duration of the certificate shal l be extended in accordance with Article 
13(3) and (5) to include the territory of Northern Ireland. 
4.  Where after the grant, in accordance with Article 10(6) of an application for an 
extension of the duration of a certificate in respe ct of a NI authorisation, an application is 
made, in accordance with Article 7(4), for an exten sion of the certificate in relation to a GB 
authorisation, the duration of the certificate shal l be extended in accordance with Article 
13(3) and (5) to include the territory of England a nd Wales and Scotland.”. 
20.  In Article 14, after paragraph (1), insert— 
“2. Where a UK authorisation is withdrawn and replaced  simultaneously with a GB 
authorisation and a NI authorisation, the certifica te granted in respect of the UK 
authorisation shall not lapse. 
3.  Where a UK, GB or NI authorisation is withdrawn, b ut one or more such authorisations 
remain valid, the protection conferred by the certi ficate shall, as from the date of 
withdrawal, no longer extend to the territory cover ed by the authorisation withdrawn but 
shall continue in respect of the territory covered by any remaining authorisation.”. 
21.  In Article 17, in paragraph (1)— 
(a)  after “Article 14”, insert “(1)”; 
(b)  after “Article 15,” insert “or if the territorial e xtent of the certificate is limited in 
accordance with Article 14(3),”. 
 
 
EXPLANATORY NOTE 
(This note is not part of the Regulations) 
These Regulations deal with matters arising out of the Protocol on Ireland/Northern Ireland 
(“Protocol”) in the Agreement on the withdrawal of the United Kingdom of Great Britain and 
Northern Ireland from the European Union and the Eu ropean Atomic Energy Community of 19 
October 2019. Union law which applies to the United  Kingdom in respect of Northern Ireland 
under Article 5(4) of the Protocol includes the fol lowing EU Directives and Regulations on 
medicinal products and plant protection products in  paragraphs 20 and 24 of Annex 2 to the 
Protocol: 
— Directive 2001/82/EC of the European Parliament a nd of the Council of 6 November 
2001 on the Community code relating to veterinary m edicinal products (OJ L311, 
28.11.2001, p.1); 
— Directive 2001/83/EC of the European Parliament a nd of the Council of 6 November 
2001 on the Community code relating to medicinal pr oducts for human use (OJ L311, 
28.11.2001, p.67); 
— Regulation (EC) No 1901/2006 of the European Parl iament and of the Council of 12 
December 2006 on medicinal products for paediatric use (OJ L378, 27.12.2006, p.1); 
— Regulation (EC) No 1107/2009 of the European Parl iament and of the Council of 21 
October 2009 concerning the placing of plant protec tion products on the market (OJ 
L309, 24.11.2009, p.1). 
The grant of a supplementary protection certificate  in relation to these products may be dependent 
on marketing authorisations provided under these Di rectives and Regulations. 
Regulations 2 and 3 amend the Patents (Amendment) ( EU Exit) Regulations 2019 (S.I. 2019/801) 
in relation to supplementary protection certificate s for medicinal products and plant protection 
products. The Patents (Amendment) (EU Exit) Regulat ions 2019 come into force on IP  13 completion day. The changes made by these Regulatio ns to the Patents (Amendment) EU Exit 
Regulations come into effect prior to IP completion  day (Regulation 1(2)). 
Regulation 4 and Part 1 of the Schedule amend Regul ation (EC) No 1610/96 of the European 
Parliament and of the Council of 23 July 1996 conce rning the creation of a supplementary 
protection certificate for plant protection product s. 
Regulation 5 and Part 2 of the Schedule amend Regul ation (EC) No 469/2009 of the European 
Parliament and of the Council of 6 May 2009 concern ing the supplementary protection certificate 
for medicinal products. 
Regulation 6 amends the Patents Rules 2007 (S.I. 20 07/3291) to provide for a new form to notify 
the comptroller of any authorisations granted after  submission of an application for a 
supplementary protection certificate. This change i s effected by amending regulation 42 of the 
Intellectual Property (Amendment etc.) (EU Exit) Re gulations 2020 (S.I. 2020/1050). 
Regulation 7 provides for transitional provisions.  
Regulations 4 to 7 come into force on IP completion  day. 
Paragraph 2 of Part 1 of the Schedule amends Articl e 1 of Regulation (EC) No 1610/96 and 
paragraph 11 of Part 2 of the Schedule amends Artic le 1 of Regulation (EC) No 469/2009 to 
introduce new definitions of “GB authorisation” and  “NI authorisation”. A “GB authorisation” 
covers the territory of Great Britain (England and Wales and Scotland) and a NI authorisation 
covers the territory of Northern Ireland. 
Paragraph 4 of Part 1 of the Schedule amends Articl e 5 of Regulation (EC) No 1610/96 and 
paragraph 13 of Part 2 of the Schedule amends Artic le 5 of Regulation (EC) No 469/2009 to 
provide that the protection conferred by a certific ate extends only to the territory in respect of 
which a valid marketing authorisation has been gran ted. 
Paragraph 7 of Part 1 of the Schedule inserts a new  Article 13A in Regulation (EC) No 1610/96 
and paragraph 19 of Part 2 of the Schedule inserts a new Article 13A in Regulation (EC) No 
469/2009. These provisions deal with the situation where a marketing authorisation has been 
applied for or granted in respect of e.g. Great Bri tain (GB), and a later authorisation is applied for  
or granted for Northern Ireland (NI). In these circ umstances, the comptroller must be notified of 
the later authorisation so that this may be publish ed. 
Paragraph 19 of Part 2 of the Schedule also inserts  a new Article 13B in Regulation (EC) No 
469/2009 to deal with extensions of the duration of  certificates granted in respect of paediatric 
uses of medicinal products. An extension of the dur ation of a certificate in respect of a GB 
authorisation is extended, in certain circumstances , to include Northern Ireland and vice versa the 
extension of the duration of a certificate in respe ct of a NI authorisation is extended to include 
Great Britain. 
The changes made by these Regulations supplement ot her changes made to UK law in relation to 
supplementary protection certificates by Parts 6 an d 8 of the Intellectual Property (Amendment 
etc.) (EU Exit) Regulations 2020 which come into fo rce on IP completion day. 
An impact assessment has not been produced for this  instrument as no, or no significant, impact 
on the private, public and voluntary sectors is for eseen. 
An explanatory memorandum is available alongside th is instrument on the Legislation UK website 
at www.legislation.gov.uk. 
  
  
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