1995R0542 — EN — 30.05.1998 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COMMISSIONREGULATION(EC)No542/95
of10March1995
concerningtheexaminationofvariationstothetermsofamarketingauthorizationfalling within
thescopeofCouncilRegulation(EEC)No2309/93
(OJ L 55, 11.3.1995, p. 15)
Amended by:
Official Journal
No page date
►M1CommissionRegulation(EC) No 1069/98 of 26 May 1998 L 153 11 27.5.1998
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COMMISSIONREGULATION(EC)No542/95
of10March1995
concerning the examination of variations to the terms of a
marketingauthorizationfallingwithinthescopeofCouncilRegula-
tion(EEC)No2309/93
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Regulation (EEC) No 2309/93 of 22 July
1993 laying down Community procedures for the authorization and
supervision of medicinal products for human and veterinary use andestablishing a European Agency for the Evaluation of MedicinalProducts(
1), and in particular Articles 15 (4) and 37 (4) thereof,
Whereas, appropriate provisions should be adopted for the examination
of variations to the terms of a marketing authorization of medicinal
products which have beenauthorized inaccordan ce with Regulation
(EEC) No 2309/93;
Whereas, it is appropriate to include a notification system or adminis-
trative procedures concerning minor variations for which it is necessaryto precisely define minor variations;
Whereas, moreover, it is necessary to distinguish from amongst those
variations which do not qualify as minor variations, those which mustbe considered to so fundamentally alter the marketing authorization,
particularly from the point of view of the quality, safety or efficacy of
a medicinal product, that a new application for a marketing authoriza-tionwould be required;
Whereas, the provisions of this Regulation are in accordance with the
opinion of the Standing Committee on Medicinal Products for HumanUse and the Standing Committee on Veterinary Medicinal Products,
HAS ADOPTED THIS REGULATION:
Scopeanddefinitions
Article 1
1. This Regulationlays downthe procedure for the examin ationof
applications for variations to the terms of a marketing authorization
granted in accordance with Regulation (EEC) No 2309/93.
2. This Regulation does not impede the marketing authorization
holder from taking provisional urgent safety restrictions in the event(SIC! restrictions. In) of risk to public or animal health. (SIC! health,the) The holder shall forthwith inform the Agency. If the Agency hasnot raised any objections within 24 hours, the urgent safety restrictions
may be introduced and the corresponding application for this variation
shall be submitted without delay to the Agency for the application ofthe procedures set out in Articles 6 and 7 of this Regulation.
3. Where the Commission imposes provisional urgent safety restric-
tions on the marketing authorisation holder, the marketing authorisation
holder shall be obliged to submit anapplicationfor a variationtakin g
account of the safety restrictions imposed by the Commission. Thisapplicationshall be submitted without delay to the Agen cy for theapplicationof the procedures set out inArticles 6 an d 7 of this Regula-tion. This paragraph is without prejudice to Article 18 of Regulation(EEC) No 2309/93.1995R0542 — EN — 30.05.1998 — 001.001 — 2
(1) OJ No L 214, 24. 8. 1993, p. 1.▼M1
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Article 2
For the purpose of this Regulation, the following definitions shall
apply;
1. ‘variation to the terms of a marketing authorization’: an amendment
to the contents of the documents referred to in Article 6 (1) and (2)or Article 28 (1) and (2) of Regulation (EEC) No 2309/93 such as
they existed at the moment the decision on the marketing authoriza-
tionhas beenadopted inaccordan ce with Article 10 or Article 32 ofthat Regulation or after approval of any previous variations, exceptwhere a new application for a marketing authorization must bepresented pursuant to Annex II to this Regulation.
2. ‘Urgent safety restriction’: an interim change to product information
by the marketing authorization holder restricting the indication(s),and/or dosage, and/or target species of the medicinal product; oradding a contra-indication, and/or warning due to new information
having a bearing on the safe use of the product.
Article 3
1. (a) A ‘minor variation’ (type I) means a variation as defined in
Article 2 and listed in Annex I to this Regulation, provided the
conditions for such variation laid down in the said Annex are
met.
(b) A ‘major variation’ (type II) means a variation as defined in
Article 2 which cannot be deemed to be a type I variation within
the meaning of the preceding paragraph.
2. For the purposes of this Regulation, transfer of marketing author-
ization to a new holder, except for the situations covered by the point 3of Annex I to this Regulation, and changes to the maximum residue
limit (MRL) shall not be considered as a variation in the meaning of
Article 2 (1).
Notificationprocedureforminorvariations
Article 4
1. To obtain a type I variation, the holder of the marketing authori-
zation shall submit to the Agency an application, accompanied bydocuments demonstrating that the conditions laid down in Annex I tothis Regulation for the requested variation are met, and all documentsamended as a result of the application.
2. An application within the meaning of paragraph 1 shall not
concern more than one variation in the marketing authorization. Whereseveral variations are to be made to a single marketing authorization,an application shall be submitted within the meaning of paragraph 1inrespect of each variationsought; each such applicationshall con taina reference to the other application(s).
3. By derogationfrom paragraph 2, where a variationinthe
marketing authorization entails one or more further changes, a singleapplication may cover all such consequential variations. The singleapplicationshall describe the relationbetweenthe mainvariationan d
its consequential variations.
4. To be valid an application within the meaning of paragraph 1
shall be consistent with the provisions of this Article and accompaniedby the relevant fee provided for in the applicable Community regula-tion.
Article 5
1. If, within30 days of receipt of a valid applicationas provided for
in Article 4, the Agency has not sent the holder of the marketingauthorizationthe n otificationprovided for inparagraph 4, the variationapplied for shall be deemed to have beenaccepted.1995R0542 — EN — 30.05.1998 — 001.001 — 3
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2. The Agency shall inform the Commission within the period
referred to inthe precedin g paragraph of the variationto be made tothe terms of the marketing authorization. The Commission shall, where
necessary, amend the decision taken pursuant to Article 10 or Article
32 of Regulation(EEC) No 2309/93. The decisionthus amen ded shalltake effect retroactively from the day following the end of the periodreferred to inparagraph 1.
3. The Community Register of Medicinal Products provided for in
Articles 12 and 34 of Regulation (EEC) No 2309/93 shall be updated
as necessary.
4. Where the Agency is of the opinion that the application cannot be
accepted, it shall send a notification to that effect to the holder of the
marketing authorization within the period referred to in paragraph 1,stating the objective grounds on which its opinion is based:
(a) within 30 days of receipt of the said notification, the marketing
authorizationholder may amen d the applicationina way whichtakes due account of the grounds set out in the notification. Inthat case the provisions of paragraphs 1, 2 and 3 shall apply to
the amended application.
(b) if the marketing authorization holder does not amend the applica-
tionas provided for in(a) above, this applicationshall be deemedto have beenrejected.
Approvalprocedure formajorvariations
Article 6
1. To obtain a type II variation, the holder of the marketing author-
ization shall send the Agency an application accompanied by therelevant particulars and supporting documents referred to in Article 2(1) of this Regulation.
The applicationmust also be accompan ied by:— the supporting data relating to the variation applied for,
— all documents amended as a result of the application,— an Addendum to or updating of existing expert report(s) to take
account of the variation applied for.
2. An application within the meaning of paragraph 1 shall not
concern more than one variation in the marketing authorization. Whereseveral variations are to be made to a single marketing authorization,an application shall be submitted within the meaning of paragraph 1inrespect of each variationsought; each such applicationshall con tain
a reference to the other application(s).
3. By derogationfrom paragraph 2, where a variationinthe
marketing authorization entails one or more further changes, a singleapplication may cover all such consequential variations. The singleapplicationshall describe the relationbetweenthe mainvariationan dits consequential variations.
4. To be valid an application within the meaning of paragraph 1
shall be consistent with the provisions of this Article and accompanied
by the relevant fee provided for in the applicable Community regula-
tion.
Article 7
1. The competent Committee of the Agency shall give its opinion
within60 days followin g receipt of a valid applicationas provided for
inArticle 6.
2. Within that period, the competent Committee may send the
marketing authorization holder a single request for information supple-mentary to that already supplied pursuant to Article 6. In this case, theperiod shall be extended by a further 60 days. This period may beextended, for a period to be determined by the competent Committee,1995R0542 — EN — 30.05.1998 — 001.001 — 4
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on its own initiative or at the request of the marketing authorization
holder.
Article 8
1. Where the competent Committee delivers an opinion, the Agency
shall inform the marketing authorisation holder and the Commission
forthwith and shall send to the Commission the amendments to bemade to the terms of the marketing authorisation accompanied by thedocuments set out in Article 9(3) and 31(3) of Regulation (EEC)No 2309/93.
2. Article 9(1) and (2) or Article 31(1) and (2) of Regulation (EEC)
No 2309/93 shall apply to the opinion adopted by the competent
Committee.
3. The decision varying the terms of the marketing authorization
shall be adopted inaccordan ce with the procedure laid downinArticle10 or Article 32 of Regulation(EEC) No 2309/93.
4. The Community Register of Medicinal Products provided for in
Articles 12 and 34 of Regulation (EEC) No 2309/93 shall be updated
as necessary.
Article 9
This Regulation shall enter into force on the third day following its
publicationinthe Official Journal of the European Communities .
This Regulation shall be binding in its entirety and directly applicable
inall Member States.1995R0542 — EN — 30.05.1998 — 001.001 — 5
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ANNEX I
MINORVARIATIONS(TYPEI)TOAMARKETINGAUTHORIZATION
ASREFERREDTOINARTICLE3(1)
Introductorystatements
A. By derogation, the procedure set out in Articles 6, 7 and 8 of the present
Regulationshall apply:
— to the minor variations Nos 11, 12, 13, 15 and 16 as referred to below
and to minor variations Nos 24 and 25 if the test procedure used is not
a physico-chemical method for medicinal products falling within the
scope of Council Directive 89/342/EEC(1), or 89/381/EEC(2), or 90/
667/EEC(3) OJ L 373, 31.12.1990, p. 26., or for medicinal products
which had been considered as arising under Part A of the Annex to
Regulation(EEC) No 2309/93,
— to any minor variation when a specific inspection of a manufacturing site
needs to be carried out.
B. Where a variation requires consequential updating of the product information
(summary of product characteristics, labelling, package and/or leaflet), this is
considered part of the variation and the time period for implementing the
consequential update must be agreed with the Agency at the time of the
approval of the variation.
1. —Change following modifications(s) of the manufacturing authoriza-
tion(s)
General condition: the modified manufacturing authorization must be
submitted to the competent authority.
—Change in the name of a manufacturer of the medicinal product
Condition to be fulfilled: the manufacturing site shall remain the same.
—Change of the manufacturing site(s) for part or all of the manufac-
turing process of the medicinal product
Condition to be fulfilled: no change either in the manufacturing process
or in the specifications, including test methods.
—Withdrawal of the manufacturing authorization for a site of manufac-
ture.
2.Change in the name of the medicinal product (either invented name or
common name)
Condition to be fulfilled: confusion with names of other existing medicinal
products or INN (International Nonproprietary Name) name must be
avoided; when the name is a common name, the change has to be made
in the following order: from common name to pharmacopoeial name or
to INN.
3.Change in the name and/or address of the marketing authorization holder
(see Article 4a of Council Directive 65/65/EEC (4)or Article 5a of Council
Directive 81/851/EEC) (5)
Condition to be fulfilled: the marketing authorization holder shall remain
the same person.
4.Replacement of an excipient with a comparable excipient (excluding adju-
vants for vaccines and biologically derived excipients)
Condition to be fulfilled: Same (SIC! same) functional characteristics, no
change in dissolution profile for solid dosage forms.
5.Change in the colouring system of the product (addition, deletion or repla-
cement of colorant(s))
Condition to be fulfilled: same functional characteristics, no change in
dissolution profile for solid dosage forms. Any minor adjustment to the
formulation to maintain the total weight should be made by an excipient
which currently makes up a major part of the formulation.1995R0542 — EN — 30.05.1998 — 001.001 — 6
(1) OJ L 142, 25.5.1989, p. 14.
(2) OJ L 181, 28.6.1989, p. 44.
(3) OJ L 373, 31. 12. 1990, p. 26.
(4) OJ No 22, 9. 2. 1965, p. 369/65.
(5) OJ No L 317, 6. 11. 1981, p. 7.▼M1
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6.Change in the flavouring system of the product (addition, deletion or
replacement of flavour(s))
Condition to be fulfilled: proposed flavour must be in accordance with
Council Directive 88/388/EEC(1). Any minor adjustment to the formula-
tion to maintain the total weight should be made by an excipient which
currently makes up a major part of the formulation.
7.Change in coating weight of tablets or change in weight of capsule shells
Condition to be fulfilled: No (SIC! no) change in dissolution profile.
8.Change in the qualitative composition of immediate packaging material
Conditions to be fulfilled: The (SIC! the) proposed packaging material
must be at least equivalent to the approved material on relevant properties,
and the change does not relate to sterile products.
9.Deletion of an indication
Conditions to be fulfilled: The (SIC! the) continued safety in use of the
medicinal product has not been the subject of concern from pharmacovigi-
lance, pre-clinical safety or quality data. Justification must be given.
10.Deletion of a route of administration
Condition to be fulfilled: The (SIC! the) continued safety in use of the
medicinal product has not been the subject of concern from pharmacovigi-
lance, pre-clinical safety or quality data. Justification must be given.
10a.Addition or replacement of measuring device for oral liquid dosage forms
and other dosage forms
Condition to be fulfilled: the size and, where applicable, the accuracy of
the proposed measuring device must be compatible with approved
posology.
11.Change in the manufacturer(s) of active substance
Condition to be fulfilled: the specifications, synthetic route and quality
control procedures are the same as those already approved or a European
Pharmacopoeia Certificate of suitability covering the active substance is
submitted.
11a.Change in the name of a manufacturer of the active substance
Condition to be fulfilled: the manufacturer of the active substance shall
remainthe same.
11b.Change in supplier of an intermediate compound used in the manufacture
of the active substance
Condition to be fulfilled: the specifications, synthetic route and quality
control procedures are the same as those already approved.
12.Minor change of manufacturing process of the active substance
Condition to be fulfilled: Specifications are not adversely affected; no
change in the physical properties, no new impurities or change in level of
impurities which would require further qualifications in safety studies.
Alternative condition: ‘… or a certificate of suitability from the European
Pharmacopeia is provided.’
12a.Change in specification of starting material or intermediate used in the
manufacture of the active substance
Condition to be fulfilled: specification must be tightened or addition of
new test and limits.
13.Batch size of active substance
Condition to be fulfilled: Batch (SIC! batch) data must show that the
change does not affect consistency of production, or physical properties.
14.Change in specifications of active substance
Condition to be fulfilled: Specifications (SIC! specifications) must be tigh-
tened or new tests and limits added.1995R0542 — EN — 30.05.1998 — 001.001 — 7
(1) OJ L 184, 15. 7. 1988, p. 61.▼B
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15.Changes in manufacture of the medicinal product
Conditions to be fulfilled: Medicinal (SIC! medicinal) product specifica-
tions are not adversely affected; the new process must lead to an identical
product regarding all aspects of quality, safety and efficacy.
15a.Change in in-process controls applied during the manufacture of the
product
Condition to be fulfilled: specification must be tightened or addition of
new test and limits.
16.Change in the batch size of finished product
Condition to be fulfilled: The (SIC! the) change does not affect consis-
tency of production.
17.Change in specification of the medicinal product
Condition to be fulfilled: Specifications (SIC! specifications) must be tigh-
tened or new tests and limits added.
18.Synthesis or recovery of non-pharmacopoeial excipients which had been
described in the original dossier
Conditions to be fulfilled: Specifications (SIC! specifications) are not
adversely affected, no new impurities or change in level of impurities
which would require further qualification in safety studies, no change in
physico-chemical properties.
19.Change in specification of excipients in the medicinal product (excluding
adjuvants for vaccines)
Condition to be fulfilled: Specifications (SIC! specifications) must be tigh-
tened or addition of new tests and limits added.
20.Extension of shelf life (SIC! shelf-life) as foreseen at time of authorization
Conditions to be fulfilled: Stability (SIC! stability) studies have been done
to the protocol which was approved at the time of the issue of the
marketing authorization; the studies must show that the agreed end of shelf
life(SIC! shelf-life) specifications are still met; the shelf life (SIC! shelf-
life)does not exceed five years.
20a.Extension of the shelf life (SIC! shelf-life) or retest period of the active
substance
Condition to be fulfilled: stability studies have been done to the protocol
which was approved at the time of the issue of the marketing authorisa-
tion; the studies must show that the agreed end of shelf life (SIC! shelf-
life)specifications are still met.
21.Change in shelf life (SIC! shelf-life) after first opening
Condition to be fulfilled: Studies (SIC! studies) must show that the agreed
end of shelf life (SIC! shelf-life) specifications are still met.
22.Change in shelf life (SIC! shelf-life) after reconstitution
Condition to be fulfilled: Studies (SIC! studies) must show that the agreed
end of shelf life (SIC! shelf-life) specifications are still met for the recon-
stituted product.
23.Change in the storage conditions
Condition to be fulfilled: Stability (SIC! stability) studies have been done
to the protocol which was approved at the time of issue of the marketing
authorization; the studies must show that the agreed end of shelf life (SIC!
shelf-life) specifications are still met.
24.Change in test procedure of active substance
Condition to be fulfilled: Results (SIC! results) of method validation show
new test procedure to be at least equivalent to the former procedure.
24a.Change in test procedure for a starting material or intermediate used in
the manufacture of the active substance
Condition to be fulfilled: results of method validation show new test
procedure to be at least equivalent to the former procedure. Specification
not adversely affected.1995R0542 — EN — 30.05.1998 — 001.001 — 8
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25.Change in test procedures of the medicinal product
Conditions to be fulfilled: Medicinal (SIC! medicinal) product specifica-
tions are not adversely affected; results of method validation show new
test procedure to be at least equivalent to the former procedure.
26.Changes to comply with supplements to pharmacopoeias ►M1(1)◄
Conditions to be fulfilled: Change (SIC! change) is made exclusively to
implement the new provisions of the supplement.
27.Change in test procedures of non-pharmacopoeial excipients
Condition to be fulfilled: Results (SIC! results) of method validation show
new test procedure to be at least equivalent to the former test procedure.
28.Change in test procedure of immediate packaging
Condition to be fulfilled: Results (SIC! results) of method of validation
show new test procedure to be at least equivalent to the former test proce-
dure.
29.Change in test procedure of administration device
Condition to be fulfilled: Results (SIC! results) of method validation show
new test procedure to be at least equivalent to the former test procedure.
30.Change in pack size for a medicinal product
Conditions to be fulfilled: Specifications (SIC! specifications) of the
medicinal product are not affected, the new size is consistent with the
dosage regimenan d durationof use as approved inthe summary of
product characteristics; the change does not relate to parenteral prepara-
tions.►M1The (SIC! The) packaging material remains the same ◄.
31.Change in container shape
Conditions to be fulfilled: No (SIC! no) change in the quality and in the
stability of the product in the container, no change in the container-product
interactions.
The change does not concern a fundamental component of the packaging
material which affects the delivery or use of the product.
32.Change of imprints, bossing or other markings (except scoring) on tablets
or printing on capsules, including addition or change of inks used for
product marking
Condition to be fulfilled: New (SIC! new) markings do not cause confu-
sionwith other tablets or capsules.
33.Change of dimensions of tablets, capsules, suppositories or pessaries
without change of quantitative composition and mean mass
Condition to be fulfilled: No (SIC! no) change in dissolution profile.
34. —Change in the manufacturing process of a non-proteinaceous compo-
nent due to a subsequent introduction of a biotechnology step
General remarks:
— This specific variation is provided to supplement the variations
already existing which can be applied in this particular context,
notably the variations Nos 4, 11, 12, 18, 19 and 26.1995R0542 — EN — 30.05.1998 — 001.001 — 9
(1) In cases where the marketing authorisation holder refers to the current edition of the
pharmacopeia, no variation application is required provided the change is introduced
within six months of adoption of the revised monograph.▼M1
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— Community legislation applicable to specific groups of products(1),
— The medicinal products containing proteinaceous component
obtained through a biotechnology process fall under the scope of
Part A of Regulation(EEC) No 2309/93.
—Change in the manufacturing process for components compliant with a
European Pharmacopoeia monographand verified by meansof a certi-
ficate of suitability from the European Pharmacopoeia
Conditions to be fulfilled: the specifications and physcio-chemical
properties and all characteristics of the component remain the same.
—Change in the manufacturing process for components requesting a new
impurities test procedure
Conditions to be fulfilled: the specifications and physico-chemical
properties and all characteristics of the component remain the same.
The manufacturing method is liable to leave impurities not controlled
inthe pharmacopoeia mon ograph, these impurities must be declared
and a suitable test procedure must be described. This supplementary
test must be specified ina certificate of suitability from the European
Pharmacopoeia.1995R0542 — EN — 30.05.1998 — 001.001 — 10
(1) Food and food ingredients compliant with Regulation (EC) No 258/97 of the European
Parliament and of the Council (OJ L 43 14.2.1997, p. 1). Colours for use in foodstuffswithin the scope of European Parliament and Council Directive 94/36/EEC (OJ L 237,
10.9.1994, p. 13), food additives of Directive 88/388/EEC, extractionsolven ts within
the meaning of Council Directive 88/344/EEC (OJ 157, 24.6.1988, p. 28), as lastamended by Directive 92/115/EEC (OJ L 409, 31.12.1992, p. 31) and foods or foodingredients derived from biotechnology step which has been introduced in the manufac-ture/production shall not require to be notified (SIC! notified,) as a variation to the
terms of the marketing authorisation.
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ANNEX II
Changes to a marketing authorization leading to a new application as
referred toinArticle 2
Certain changes to a marketing authorisation have to be considered to funda-
mentally alter the terms of this authorisation and therefore cannot be
considered as a variation in the meaning of Article 15 paragraph 4 of Regulation
(EEC) No 2309/93 and cannot be granted following a variation procedure. Forthese changes, listed below, any new application has to be considered within a
complete scientific evaluation procedure (as for the granting of a marketing
authorisation). As the case may be, an authorisation of a modification of the
existing marketing authorisation will have to be granted by the Community.
This Annex is without prejudice to the provisions of Article 4 of Directive 65/
65/EEC and Article 5 of Directive 81/851/EEC.
1.Changes to the active substance(s):
(i) addition of one or more active substance(s) including antigenic compo-
nents for vaccines;
(ii) deletion of one or more active substance(s) including antigenic compo-
nents for vaccines;
(iii) quantitative change to the active substance(s);
(iv) replacement of the active substance(s) by a different salt/ester complex/
derivative (with the same therapeutic moiety);
(v) replacement by a different isomer, a different mixture of isomers, of a
mixture by an isolated isomer (e.g. racemate by a single enantiomer);
(vi) replacement of a biological substance or product of biotechnology with
one of a different molecular structure; modification of the vector used
to produce the antigen/source material, including a master cell bank
from a different source;
(vii) a new ligand or coupling mechanism for a radiopharmaceutical.
2.Changes to the therapeutic indications (
1):
(i) addition of an indication in a different therapeutic area, either treatment,
diagnosis or prophylaxis;
(ii) change of the indication to a different therapeutic area, either treatment,
diagnosis or prophylaxis.
3.Changes to strength, pharmaceutical form and route of administration (2):
(i) change of bioavailability;
(ii) change of pharmacokinetics e.g. change in rate of release;
(iii) addition of a new strength;
(iv) change or addition of a new pharmaceutical form;
(v) addition of a new route of administration.
4.Other changes specific to veterinary medicinal products to be administered
to food-producing animals:
(i) additionor chan ge of target species;
(ii) shortening of the withdrawal period of a veterinary medicinal product if
the change is not linked to the establishment or a modification of a
maximum residue limit in accordance with Council Regulation (EEC)
No 2377/90(3).1995R0542 — EN — 30.05.1998 — 001.001 — 11
(1) Therapeutic area is defined as the third level of the Anatomical Therapeutic Chemical
(A.T.C./A.T.C. Vet) code.
(2) For parenteral administration, it is necessary to distinguish between intraarterial, intra-
venous, intramuscular, subcutaneous, and other routes. For administration to poultry,respiratory, oral, ocular (nebulization) routes used for vaccination are considered to bethe equivalent routes of administration.
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