B 1725
L.N. 234 of 2022
MEDICINES ACT
(CAP. 458)
Medicinal Products for Human Use (Derogations from certain 
obligations) Regulations, 2022
IN EXERCISE of the powers c onferred by article 106 of the
Medicines Act, the Minister responsible for public health, afte r
consultation with the Licensing Authority, has made the followi ng
regulations:- 
Citation.
Commencement.1. The title of these regulations is the Medicinal Products for
Human Use (Derogations from cert ain obligations) Regulations, 2 022.
2. These regulations shall be de emed to have come into force
on the 1st January 2022.
Scope. 3. The scope of these regulations i s to transpose Directive (EU)
2022/642 of the European Parliame nt and of the Council of 12 Ap ril
2022 amending Directives 2001/20/ EC and 2001/83/EC as regards
derogations from certain obligat ions concerning certain medicin al
products for human use made available in the United Kingdom in
respect of Northern Ireland and in Cyprus, Ireland and Malta.
Derogations. 4. The derogations stipulated in these regulations are for the
purpose of preventing shortages of medicinal products and ultim ately
to ensure a high level of public health protection. By virtue of thesederogations medicinal products from or transiting through parts  of the
United Kingdom, may temporarily be allowed.
Part I
Amendments to the Medicines (Marketing Authorisation) 
Regulations
Amendments to 
the Medicines (Marketing 
Authorisation) 
Regulations.S.L. 458.34.5. This Part amends the Medicines (Marketing Authorisation)
Regulations and it shall be read and construed as one with the Medicines
(Marketing Authorisation) Regulat ions, hereinafter in this Part  referred
to as the "the principal regulations".
Adds new 
regulation 2A to 
the principal regulations. 6. Immediately after regulation 2 of the principal regulations
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there shall be added the following new regulation:
Adds new 
regulation 4A to 
the principal 
regulations. 7. Immediately after regulation 4 of the principal regulations
there shall be added the following new regulation:"List of medicinal 
products to be 
published.   2A. (1) The Licensing Authority shall establish,
notify to the Commissi on and publish on its website a list of
medicinal products to which it has applied or intends to
apply the derogations as set out in Directive (EU) 2022/642
of the European Parliament and of the Council of 12 April
2022;
 (2) The Licensing Authority shall ensure that the list
referred to in sub-regulation (1) is updated and managed in
an independent manner, at le ast on a six-monthly basis.".
"Derogation 
for products 
from the United 
Kingdom.4A. (1) By way of derogation from regulation
4(2), until the 31st December 2024, in the absence of a
marketing authorisation or o f a pending application for a
marketing authorisation, the Licensing Authority mayauthorise for justified public health reasons the placing onthe market of a medicinal pro duct authorised in parts of the
United Kingdom other than Northern Ireland:
Provided that the Licensing Authority may also
maintain in force or, until the 31st December 2024, extendmarketing authorisations that were granted pursuant to this
sub-regulation before the 20th April 2022 which authorise
the placing on the market of a medicinal product authorised
in parts of the United Kingdom other than Northern Ireland:
Provided further that authorisations that are
granted, extended or maintained in force pursuant to theprovisions of this sub-regulation shall not be valid after the
31st December 2026.
(2) By way of derogation from regulation 5(1)(b),
the Licensing Author ity may grant market ing authorisations
as referred to in regulation 4( 2), to marketing authorisation
holders established in part s of the United Kingdom other
than Northern Ireland.
(3) Where the Licensing Authority grants or
extends a marketing authorisa tion as referred to in sub-
regulation (1), it shall en sure compliance with the
requirements of this regulation.
(4) Before granting a marketing authorisation
pursuant to sub-regulation ( 1), the Licensing Authority:
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Amends 
regulation 5 of the principal 
regulations. 8. In regulation 5(1)(b) of the p rincipal regulations the words
"established in the Community;"  shall be substituted by the wor ds
"established in the Community:" a nd immediately after there sha ll be
added the following new provisos:
Adds new 
regulation 5A to 
the principal 
regulations. 9. Immediately after regulation 5 of the principal regulations
there shall be added the following new regulation:(a) shall notify the marketing authorisation
holder in parts of the United Kingdom other than
Northern Ireland of the pr oposal to grant a marketing
authorisation or to extend a marketing authorisation
under this regulation in r espect of the medicinal
product concerned;
(b) may request the competent authority in the
United Kingdom to submit the  relevant information
regarding the marketing authorisation of themedicinal product concerned.".
 "Provided that by way of derogation from the above,
marketing authorisations may be granted until the 31st December  2024,
by the Licensing Authority in accordance with the mutual recogn ition
or the decentralised procedure laid down under regulation 22 to
marketing authorisation holders e stablished in parts of the Uni ted
Kingdom other than Northern Ireland:
 Provided further that unt il the 31st December 2024 the
Licensing Authority may extend ma rketing authorisations already
granted prior to the 20th Apr il 2022 to marketing authorisation  holders
established in parts of the United Kingdom other than Northern Ireland:
 Provided further that marketing authorisations granted or
extended by the Licensing Authorit y in accordance with the prec eding
two provisos shall cease to be valid at the latest on the 31st December
2026.".
"Obligations of 
the authorisation 
holder.
S.L. 458.35.
S.L. 458.36.5A. The derogations set out in regulations 4A and
5(1) (b), regulations 4 and 22 of the Pharmacovigilance
Regulations, and regulations 11A, 11B, 11C and 11D of the
Manufacture and Importation of Medicinal Products forHuman Use Regulations shall not affect the obligations of
the marketing authorisation holder to ensure the quality,
safety and efficacy of the medicinal product placed on the
market as laid down in these regulations.".
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Part II
Amendments to the Pharma covigilance Regulations
Amendments to the 
Pharmacovigilance 
Regulations
S.L. 458.35.10. This Part amends the Pharmac ovigilance Regulations and it
shall be read and construed as one with the Pharmacovigilance
Regulations, hereinafter in this P a r t  r e f e r r e d  t o  a s  t h e  " t h e  p rincipal
regulations".
Amends 
regulation 6 of the principal 
regulations.11. In the proviso to regulation 6( 4) of the principal regulations
the words "and the Agency." shall be substituted by the words "and the
Agency:" and immediately thereaft er there shall be added the fo llowing
new proviso:
Part III
Amendments to the Manufacture a nd Importation of Medicinal 
Products  for Human Use Regulations
Amendments to the 
Manufacture and 
Importation of Medicinal Products 
for Human Use 
Regulations.S.L. 458.36.12. This Part amends the Manufacture and Importation of
Medicinal Products for Human Use  Regulations and it shall be re ad and
construed as one with the Manufact ure and Importation of Medici nal
Products for Human Use Regulatio ns, hereinafter in this Part referred to
as the "the princi pal regulations".
Amends 
regulation 11 of 
the principal regulations. 13. Regulation 11 of the principal r egulations shall be amended
as follows:
(a) in the Maltese version only, in paragraph (a) of sub-
regulation (1) thereof, the words "konsenja ta’ prodotti
mediċinali manifatturati f’Mal ta tkun ġiet manifatturata u
verifikata" shall be  substituted by the words "lott ta’ prodott i
mediċinali manifatturati f’ Malta jkun ġie manifatturat u
verifikat";
(b) in the Maltese version only, in paragraph (b) of sub-
regulation (1) thereof, the w ords "konsenja tal-produzzjoni
għandha tkun għaddiet" shall be substituted by the words "lott "Provided further that by way of derogation from the
preceding proviso, where the mark eting authorisation is granted
by the competent authority of the United Kingdom in respect of
Northern Ireland, the qualified person referred to in paragraph
(a) of this sub-regulation may reside and operate in parts of theUnited Kingdom other than Northe rn Ireland. This proviso shall
not apply where the marketing au thorisation holder already has
at its disposal a qualified person who resides and operates in the
European Union on 20 April 2022.". 
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tal-produzzjoni għandu jkun għadda";
(c) in the Maltese version only, in the proviso to
paragraph (b) of sub-regulation (1) thereof, the word "konsenji "
shall be substituted by the word "lottijiet".
Adds new 
regulations 11A, 
11B, 11C and 
11D to the principal 
regulations.14. Immediately after regulation 11 of the principal regulations
there shall be added the f ollowing new regulations:
"Quality control testing 
in the United Kingdom.
S.L. 458.34.11A.  With regard to quality control testing, carried
out in parts of the United Kingdom other than Northern
Ireland, regarding medicinal products included in the list
referred to in regulation 5A o f the Medicines (Marketing
Authorisation) Regulations oth er than those authorised by
the Commission, until the 31st December 2022, the
Licensing Authority, may consider  there is a justifiable case
within the meaning of regulati on 11(1)(b), without carrying
out a case-by-case assessment provided that: 
(a) each batch of the medicinal products
concerned is released by a qualified person on a sitein the Union or in Northern Ireland or by a qualified
person on a site in parts of the United Kingdomother than Northern Ireland applying quality
standards that are equivalent to those laid down in
regulation 11;
(b) the establishment designated by the third
party conducting the quality control testing issupervised by the competent authority of the United
Kingdom, including by performing on-the-spot
checks;
(c) where the batch release is carried out by a
qualified person who resides and operates in parts ofthe United Kingdom other than Northern Ireland, the
manufacturing authorisati on holder declares that it
does not have at its disposal a qualified person whoresides and operates in the Union on the 20th
 April
2022.
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Derogation 
from the 
requirement of 
an importers’ licence.
S.L. 458.37.11B. By way of derogation from sub-regulations
1(a) and (b) of regulation 3, until the 31st December 2024,
the Licensing Authority shall allow medicinal products to
be imported from parts of the United Kingdom other thanNorthern Ireland by holders of a wholesale distributionauthorisation as referred to in regulation 4 of the
Wholesale Distribution and Brokering of Medicinal
Products and Active Substances  Regulations, that are not
in possession of a relevant m anufacturing authorisation
provided that all of the following conditions are fulfilled:
(a) the medicinal products have undergone
quality control testing, either in the Union, asprovided for in regulation 12 or in parts of the
United Kingdom other than Northern Ireland in
compliance with regulation 11(1)(b);
(b) the medicinal products have been subject
to batch release by a qualified person in the Union inaccordance with regulation 11(1) or, for medicinal
products authorised by the Licensing Authority and
the United Kingdom in respect of Northern Ireland, inparts of the United Kingdo m other than Northern
Ireland applying quality standards that are equivalentto those laid down in regulation 11(1);
(c) the marketing authorisation for the
medicinal product concerned has been granted inaccordance with Union law, by the competent
authority of a Member State or by the Commission or,
as regards medicinal pr oducts placed on the market in
Northern Ireland, by the competent authority of the
United Kingdom in respe ct of Northern Ireland;
(d) medicinal products are only made
available to patients or end-consumers in Malta;
S.L. 458.33.(e) the medicinal products bear the safety
features referred to in regulation 3(o) of the Medicinal
Products (Labelling and Pack aging) Regulations. 
Certain 
derogations 
from 
importation controls.11C. For batches of medicinal products exported to
parts of the United Kingdom other than Northern Ireland
from a Member State and subsequently imported into
Malta until the 31st December 2024 the controls upon
importation referred to in the  sub-regulations (1) and (2)
of regulation 11, shall not be required, provided that those
batches have undergone such controls in a Member State
prior to being exported to p arts of the United Kingdom
other than Northern Ireland and that they are accompaniedby the control reports referre d to in the said regulation.
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Amends 
regulation 12 of 
the principal 
regulations. 15. In the Maltese version only, i n regulation 12(1) the words
"konsenja li tkun ġiet prodotta t kun tissodisfa" shall be subst ituted by
the words "lott li jkun ġie  prodott ikun jissodisfa".
Part IV
Amendments to the Wholesale Di stribution and Brokering of 
Medicinal Products and Active Substances Regulations
Amendments to the 
Wholesale Distribution and 
Brokering of 
Medicinal Products and Active 
Substances 
Regulations.
S.L. 458.37.16. This Part amends the Wholesal e Distribution and Brokering
of Medicinal Products and Active Substances Regulations and it shall
be read and construed as one with the Wholesale Distribution an d
Brokering of Medicinal Products a nd Active Substances Regulatio ns,
hereinafter in this Part referred to as the "the principal regu lations".
Amends 
regulation 3 of the principal 
regulations.17. In the Maltese version only, in t he proviso to regulation 3(2)
of the principal regulations the  word "kunsinna" shall be subst ituted by
the word "lott".
Amends 
regulation 8 of the principal 
regulations.18. Regulation 8(2) of the principa l regulations shall be amended
as follows:
(a) in the proviso to paragraph (b) thereof, the words
"end up on any Member State market;" shall be substituted by
the words "end up on any Member State market:" and
immediately after there shal l be added the following new
proviso:
(b) in the Maltese version only, in sub-paragraph (v) of
paragraph (e) thereof, the word "kunsina" shall be substituted by
the word "lott".Derogation 
regarding the 
place of 
operation of the qualified 
person.11D. Where the manufacturing authorisation is
granted by the competent authority of the United Kingdom
in respect of Northern Ireland, the qualified person referred
to regulation 11(1) may reside and operate in parts of the
United Kingdom other than Northern Ireland, unless themanufacturing authorisation holder already has at its
disposal a qualified person who resides and operates in theUnion on 20 April 2022.". 
S.L. 458.36. "Provided further that the requirements of the
above proviso shall not apply to the import of a medicinal
product meeting the conditi ons laid down in regulation 11B
of the Manufacture and Importation of Medicinal Products
for Human Use Regulations;".
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Amends 
regulation 9 of 
the principal regulations.19.  In the Maltese version only, in regulation 9(1) of the
principal regulations the word "kunsinna" shall be substituted by the
word "lott".
Part V
Amendments to the Good Clinical Practice and Requirements for 
Manufacturing or Import Authorisation of Investigational 
Medicinal Products (Human Use) Regulations
Amendments to the 
Good Clinical Practice and 
Requirements for 
Manufacturing or Import 
Authorisation of 
Investigational Medicinal Products 
(Human Use) 
Regulation.S.L. 458.47.20. This Part amends the Good Clinical Practice and
Requirements for Manufacturing or Import Authorisation of
Investigational Medicinal Products (Human Use) Regulations and it
shall be read and construed as one with the  Good Clinical Practice and
Requirements for Manufacturing or Import Authorisation ofInvestigational Medicinal Products (Human Use) Regulations,hereinafter in this Part referred to as the "the principal regulations".
Amends 
regulation 7 of 
the principal 
regulations. 21. In sub-regulation (1) of regulation 7 of the principal
regulations the words "dividing up, packaging or presentation."  shall be
substituted by the words "divid ing up, packaging or presentatio n:" and
immediately after there shall be added the following new proviso:
"Provided that by way of derogation from sub-
regulation (1), the Licensing Authority shall allow
investigational medicinal products to be im ported from parts of
the United Kingdom other than Northern Ireland without such
an authorisation provided that all of the following conditions are
fulfilled:
(a) the imported investigational medicinal
products have undergone certification of batch release
either in the Union, as provided for in paragraph 3, point
(a) of Article 13 (1) of Directive 2001/20/EC, or in parts of
the United Kingdom other than Northern Ireland incompliance with the requirements set out in paragraph 3,
point (b) of the same Directive;
(b) the imported investigational medicinal
products are only made available in Malta.".
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