DIRECTIVE 2011/62/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  
of 8 June 2011  
amending Directive 2001/83/EC on the Community code relating to medicinal products for human 
use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products  
(Text with EEA relevance)  
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE 
EUROPEAN UNION,  
Having regard to the Treaty on the Functioning of the European 
Union, and in particular Article 114, and point (c) of 
Article 168(4), thereof,  
Having regard to the proposal from the European Commission,  
Having regard to the opinion of the European Economic and 
Social Committee (  1 ), 
Having regard to the opinion of the Committee of the 
Regions (  2 ), 
Acting in accordance with the ordinary legislative procedure (  3 ), 
Whereas:  
(1) Directive 2001/83/EC of the European Parliament and of 
the Council (  4 ) lays down the rules for, inter alia, manu ­
facturing, importing, placing on the market, and the 
wholesale distribution of medicinal products in the 
Union as well as rules relating to active substances.  
(2) There is an alarming increase of medicinal products 
detected in the Union which are falsified in relation to 
their identity, history or source. Those products usually 
contain sub-standard or falsified ingredients, or no 
ingredients or ingredients, including active substances, 
in the wrong dosage thus posing an important threat 
to public health.  
(3) Past experience shows that such falsified medicinal 
products do not reach patients only through illegal 
means, but via the legal supply chain as well. This 
poses a particular threat to human health and may lead 
to a lack of trust of the patient also in the legal supply 
chain. Directive 2001/83/EC should be amended in order 
to respond to this increasing threat.  
(4) The threat to public health is also recognised by the 
World Health Organisation (WHO), which set up the 
International Medical Products Anti-Counterfeiting 
Taskforce (‘IMPACT’). IMPACT developed Principles and 
Elements for National Legislation against Counterfeit 
Medical Products, which were endorsed by the IMPACT 
General Meeting in Lisbon on 12 December 2007. The 
Union participated actively in IMPACT.  
(5) A definition of ‘falsified medicinal product’ should be 
introduced in order to clearly distinguish falsified medicinal products from other illegal medicinal products, 
as well as from products infringing intellectual property 
rights. Furthermore, medicinal products with uninten ­
tional quality defects resulting from manufacturing or 
distribution errors should not be confused with falsified 
medicinal products. To ensure uniform application of 
this Directive, the terms ‘active substance’ and ‘excipient’ 
should also be defined.  
(6) Persons procuring, holding, storing, supplying or 
exporting medicinal products are only entitled to 
pursue their activities if they meet the requirements for 
obtaining a wholesale distribution authorisation in 
accordance with Directive 2001/83/EC. However, 
today’s distribution network for medicinal products is 
increasingly complex and involves many players who 
are not necessarily wholesale distributors as referred to 
in that Directive. In order to ensure the reliability of the 
supply chain, legislation in relation to medicinal products 
should address all actors in the supply chain. This 
includes not only wholesale distributors, whether or 
not they physically handle the medicinal products, but 
also brokers who are involved in the sale or purchase of 
medicinal products without selling or purchasing those 
products themselves, and without owning and physically 
handling the medicinal products.  
(7) Falsified active substances and active substances that do 
not comply with applicable requirements of Directive 
2001/83/EC pose serious risks to public health. Those 
risks should be addressed by strengthening the verifi ­
cation requirements applicable to the manufacturer of 
the medicinal product.  
(8) There is a range of different good manufacturing 
practices that are suitable for being applied to the manu ­
facturing of excipients. In order to provide for a high 
level of protection of public health, the manufacturer 
of the medicinal product should assess the suitability of 
excipients on the basis of appropriate good manufac ­
turing practices for excipients.  
(9) In order to facilitate enforcement of and control of 
compliance with Union rules relating to active 
substances, the manufacturers, importers or distributors 
of those substances should notify the competent 
authorities concerned of their activities.  
(10) Medicinal products may be introduced into the Union 
while not being intended to be imported, i.e. not 
intended to be released for free circulation. If those 
medicinal products are falsified they present a risk to 
public health within the Union. In addition, those 
falsified medicinal products may reach patients in third 
countries. Member States should take measures to 
prevent these falsified medicinal products, if introducedEN L 174/74 Official Journal of the European Union 1.7.2011  
( 1 ) OJ C 317, 23.12.2009, p. 62.  
( 2 ) OJ C 79, 27.3.2010, p. 50.  
( 3 ) Position of the European Parliament of 16 February 2011 (not yet 
published in the Official Journal) and decision of the Council of 
27 May 2011.  
( 4 ) OJ L 311, 28.11.2001, p. 67.into the Union, from entering into circulation. When 
adopting provisions supplementing this obligation on 
Member States to take those measures, the Commission 
should take account of the administrative resources 
available and the practical implications, as well as the 
need to maintain swift trade flows for legitimate 
medicinal products. Those provisions should be without 
prejudice to customs legislation, to the distribution of 
competences between the Union and the Member 
States and to the distribution of responsibilities within 
Member States.  
(11) Safety features for medicinal products should be 
harmonised within the Union in order to take account 
of new risk profiles, while ensuring the functioning of 
the internal market for medicinal products. Those safety 
features should allow verification of the authenticity and 
identification of individual packs, and provide evidence of 
tampering. The scope of these safety features should take 
due account of the particularities of certain medicinal 
products or categories of medicinal products, such as 
generic medicinal products. Medicinal products subject 
to prescription should as a general rule bear the safety 
features. However, in view of the risk of falsification and 
the risk arising from falsification of medicinal products 
or categories of medicinal products there should be the 
possibility to exclude certain medicinal products or 
categories of medicinal products subject to prescription 
from the requirement to bear the safety features by way 
of a delegated act, following a risk assessment. Safety 
features should not be introduced for medicinal 
products or categories of medicinal products not 
subject to prescription unless, by way of exception, an 
assessment shows the risk of falsification, which leads to 
serious consequences. Those medicinal products should 
accordingly be listed in a delegated act.  
The risk assessments should consider aspects such as the 
price of the medicinal product; previous cases of falsified 
medicinal products being reported in the Union and in 
third countries; the implications of a falsification for 
public health, taking into account the specific char ­
acteristics of the products concerned; and the severity 
of the conditions intended to be treated. The safety 
features should allow the verification of each supplied 
pack of the medicinal products, regardless of how they 
are supplied including through sale at a distance. The 
unique identifier as well as the corresponding repositories 
system should apply without prejudice to Directive 
95/46/EC of the European Parliament and of the 
Council of 24 October 1995 on the protection of indi ­
viduals with regard to the processing of personal data 
and on the free movement of such data (  1 ) and should 
retain clear and effective safeguards whenever personal 
data is processed. The repositories system containing 
information on safety features might include 
commercially sensitive information. This information 
must be appropriately protected. When introducing the 
obligatory safety features, due account should be taken of 
the particular characteristics of the supply chains in 
Member States.  
(12) Any actor in the supply chain who packages medicinal 
products has to be a holder of a manufacturing auth ­orisation. In order for the safety features to be effective, a 
manufacturing authorisation holder who is not himself 
the original manufacturer of the medicinal product 
should only be permitted to remove, replace or cover 
those safety features under strict conditions. In particular, 
the safety features should be replaced in the case of 
repackaging by equivalent safety features. To this end, 
the meaning of the term ‘equivalent’ should be clearly 
specified. Those strict conditions should provide 
adequate safeguards against falsified medicinal products 
entering the supply chain, in order to protect patients as 
well as the interests of marketing authorisation holders 
and manufacturers.  
(13) Manufacturing authorisation holders who repackage 
medicinal products should be liable for damages in the 
cases and under the conditions set out in Council 
Directive 85/374/EEC of 25 July 1985 on the approxi ­
mation of the laws, regulations and administrative 
provisions of the Member States concerning liability for 
defective products (  2 ). 
(14) In order to increase reliability in the supply chain, 
wholesale distributors should verify that their supplying 
wholesale distributors are holders of a wholesale 
distribution authorisation.  
(15) The provisions applicable to the export of medicinal 
products from the Union and those applicable to the 
introduction of medicinal products into the Union with 
the sole purpose of exporting them need to be clarified. 
Under Directive 2001/83/EC a person exporting 
medicinal products is a wholesale distributor. The 
provisions applicable to wholesale distributors as well 
as good distribution practices should apply to all those 
activities whenever they are performed on Union 
territory, including in areas such as free trade zones or 
free warehouses.  
(16) In order to ensure transparency, a list of wholesale 
distributors for whom it has been established that they 
comply with applicable Union legislation by means of an 
inspection by a competent authority of a Member State, 
should be published in a database that should be estab ­
lished at Union level.  
(17) The provisions on inspections and controls of all actors 
involved in the manufacturing and supply of medicinal 
products and their ingredients should be clarified and 
specific provisions should apply to different types of 
actors. This should not prevent Member States from 
performing additional inspections, where considered 
appropriate.  
(18) In order to ensure a similar level of protection of human 
health throughout the Union, and to avoid distortions in 
the internal market, the harmonised principles and 
guidelines for inspections of manufacturers and 
wholesale distributors of medicinal products as wellEN 1.7.2011 Official Journal of the European Union L 174/75  
( 1 ) OJ L 281, 23.11.1995, p. 31.  (  2 ) OJ L 210, 7.8.1985, p. 29.as of active substances should be strengthened. Such 
harmonised principles and guidelines should also help 
to ensure the functioning of existing mutual recognition 
agreements with third countries whose application 
depends on efficient and comparable inspection and 
enforcement throughout the Union.  
(19) Manufacturing plants of active substances should be 
subject not only to inspections carried out on the 
grounds of suspected non-compliance but also on the 
basis of a risk-analysis.  
(20) The manufacture of active substances should be subject 
to good manufacturing practice regardless of whether 
those active substances are manufactured in the Union 
or imported. With regard to the manufacture of active 
substances in third countries, it should be ensured that 
the legislative provisions applicable to the manufacturing 
of active substances intended for export to the Union, as 
well as inspections of facilities and enforcement of the 
applicable provisions, provide for a level of protection of 
public health equivalent to that provided for by Union 
law.  
(21) The illegal sale of medicinal products to the public via 
the Internet is an important threat to public health as 
falsified medicinal products may reach the public in this 
way. It is necessary to address this threat. In doing so, 
account should be taken of the fact that specific 
conditions for retail supply of medicinal products to 
the public have not been harmonised at Union level 
and, therefore, Member States may impose conditions 
for supplying medicinal products to the public within 
the limits of the Treaty on the Functioning of the 
European Union (TFEU).  
(22) When examining the compatibility with Union law of the 
conditions for the retail supply of medicinal products, the 
Court of Justice of the European Union (‘the Court of 
Justice’) has recognised the very particular nature of 
medicinal products, whose therapeutic effects distinguish 
them substantially from other goods. The Court of Justice 
has also held that health and life of humans rank 
foremost among the assets and interests protected by 
the TFEU and that it is for Member States to determine 
the level of protection which they wish to afford to 
public health and the way in which that level has to 
be achieved. Since that level may vary from one 
Member State to another, Member States must be 
allowed discretion (  1 ) as regards the conditions for the 
supply on their territory of medicinal products to the 
public.  
(23) In particular, in the light of the risks to public health and 
given the power accorded to Member States to determine 
the level of protection of public health, the case-law of 
the Court of Justice has recognised that Member States 
may, in principle, restrict the retail sale of medicinal 
products to pharmacists alone (  2 ). (24) Therefore, and in the light of the case-law of the Court of 
Justice, Member States should be able to impose 
conditions justified by the protection of public health 
upon the retail supply of medicinal products offered 
for sale at a distance by means of information society 
services. Such conditions should not unduly restrict the 
functioning of the internal market.  
(25) The public should be assisted in identifying websites 
which are legally offering medicinal products for sale at 
a distance to the public. A common logo should be 
established, which is recognisable throughout the 
Union, while allowing for the identification of the 
Member State where the person offering medicinal 
products for sale at a distance is established. The 
Commission should develop the design for such a logo. 
Websites offering medicinal products for sale at a 
distance to the public should be linked to the website 
of the competent authority concerned. The websites of 
the competent authorities of Member States, as well as 
that of the European Medicines Agency (‘the Agency’), 
should give an explanation of the use of the logo. All 
those websites should be linked in order to provide 
comprehensive information to the public.  
(26) In addition, the Commission should, in cooperation with 
the Agency and Member States, run awareness campaigns 
to warn of the risks of purchasing medicinal products 
from illegal sources via the Internet.  
(27) Member States should impose effective penalties for acts 
involving falsified medicinal products taking into account 
the threat to public health posed by those products.  
(28) The falsification of medicinal products is a global 
problem, requiring effective and enhanced international 
coordination and cooperation in order to ensure that 
anti-falsification strategies are more effective, in particular 
as regards sale of such products via the Internet. To that 
end, the Commission and the Member States should 
cooperate closely and support ongoing work in inter ­
national fora on this subject, such as the Council of 
Europe, Europol and the United Nations. In addition, 
the Commission, working closely with Member States, 
should cooperate with the competent authorities of 
third countries with a view to effectively combating the 
trade in falsified medicinal products at a global level.  
(29) This Directive is without prejudice to provisions 
concerning intellectual property rights. It aims specifically 
to prevent falsified medicinal products from entering the 
legal supply chain.  
(30) The Commission should be empowered to adopt 
delegated acts in accordance with Article 290 TFEU in 
order to supplement the provisions of Directive 
2001/83/EC, as amended by this Directive, concerning 
good manufacturing and distribution practices for 
active substances, concerning detailed rules for 
medicinal products introduced into the Union without 
being imported and concerning safety features. It is of 
particular importance that the Commission carryEN L 174/76 Official Journal of the European Union 1.7.2011  
( 1 ) Judgment of the Court of 19 May 2009 in Joined Cases C-171/07 
and C-172/07  Apothekerkammer des Saarlandes and Others  v Saarland  
ECR [2009] I-4171, paragraphs 19 and 31.  
( 2 ) Judgment of the Court of 19 May 2009 in Joined Cases C-171/07 
and C-172/07  Apothekerkammer des Saarlandes and Others  v Saarland  
ECR [2009] I-4171, paragraphs 34 and 35.out appropriate consultations during its preparatory 
work, including at expert level. The Commission, when 
preparing and drawing up delegated acts, should ensure a 
simultaneous, timely and appropriate transmission of 
relevant documents to the European Parliament and 
Council.  
(31) In order to ensure uniform conditions for implemen ­
tation, implementing powers should be conferred on 
the Commission as regards the adoption of measures 
for the assessment of the regulatory framework 
applicable to the manufacturing of active substances 
exported from third countries to the Union and as 
regards a common logo that identifies websites which 
are legally offering medicinal products for sale at a 
distance to the public. Those powers should be 
exercised in accordance with Regulation (EU) No 
182/2011 of the European Parliament and of the 
Council of 16 February 2011 laying down the rules 
and general principles concerning mechanisms for 
control by Member States of the Commission’s exercise 
of implementing powers (  1 ). 
(32) The safety features for medicinal products introduced 
under this Directive require substantial adaptations to 
manufacturing processes. In order to enable manu ­
facturers to make those adaptations, the time limits for 
the application of the provisions on the safety features 
should be sufficiently long and should be calculated as 
from the date of publication in the  Official Journal of the 
European Union  of the delegated acts setting out detailed 
rules in relation to those safety features. It should also be 
taken into account that some Member States already have 
a national system in place. Those Member States should 
be granted an additional transitional period for adapting 
to the harmonised Union system.  
(33) Since the objective of this Directive, namely to safeguard 
the functioning of the internal market for medicinal 
products, whilst ensuring a high level of protection of 
public health against falsified medicinal products, cannot 
be sufficiently achieved by the Member States, and can, 
by reason of the scale of the measure, be better achieved 
at Union level, the Union may adopt measures, in 
accordance with the principle of subsidiarity as set out 
in Article 5 of the Treaty on European Union. In 
accordance with the principle of proportionality, as set 
out in that Article, this Directive does not go beyond 
what is necessary in order to achieve that objective.  
(34) It is important that the competent authorities of the 
Member States, the Commission and the Agency 
cooperate to ensure the exchange of information on 
measures taken to combat the falsification of medicinal 
products and on the penalties systems that are in place. 
Currently, such exchange takes place through the 
Working Group of Enforcement Officers. Member 
States should ensure that patients’ and consumers’ 
organisations are kept informed about enforcement 
activities to the extent that this is compatible with oper ­
ational needs.  (35) In accordance with point 34 of the Interinstitutional 
Agreement on better law-making (  2 ), Member States are 
encouraged to draw up, for themselves and in the 
interests of the Union, their own tables illustrating, as 
far as possible, the correlation between this Directive 
and the transposition measures, and to make them 
public.  
(36) Directive 2001/83/EC was recently amended by Directive 
2010/84/EU (  3 ) as regards pharmacovigilance. That 
Directive, inter alia, amended Article 111 with regard 
to inspections and Article 116 with regard to the 
suspension and revocation and variation of marketing 
authorisations under certain circumstances. Furthermore, 
it inserted provisions on delegated acts in Articles 121a, 
121b and 121c of Directive 2001/83/EC. This Directive 
requires some further and complementary changes to 
those Articles of Directive 2001/83/EC.  
(37) Directive 2001/83/EC should be amended accordingly,  
HAVE ADOPTED THIS DIRECTIVE:  
Article 1  
Directive 2001/83/EC is hereby amended as follows:  
(1) Article 1 is amended as follows:  
(a) the following points are inserted:  
‘3a. Active substance:  
Any substance or mixture of substances intended 
to be used in the manufacture of a medicinal 
product and that, when used in its production, 
becomes an active ingredient of that product 
intended to exert a pharmacological, immuno ­
logical or metabolic action with a view to 
restoring, correcting or modifying physiological 
functions or to make a medical diagnosis.  
3b. Excipient:  
Any constituent of a medicinal product other 
than the active substance and the packaging 
material.’;  
(b) the following point is inserted:  
‘17a. Brokering of medicinal products:  
All activities in relation to the sale or purchase 
of medicinal products, except for wholesale 
distribution, that do not include physical 
handling and that consist of negotiating inde ­
pendently and on behalf of another legal or 
natural person.’;  
(c) the following point is added:  
‘33. Falsified medicinal product:EN 1.7.2011 Official Journal of the European Union L 174/77  
( 1 ) OJ L 55, 28.2.2011, p. 13.  ( 2 ) OJ C 321, 31.12.2003, p. 1.  
( 3 ) OJ L 348, 31.12.2010, p. 74.Any medicinal product with a false representation 
of: 
(a) its identity, including its packaging and 
labelling, its name or its composition as 
regards any of the ingredients including 
excipients and the strength of those 
ingredients;  
(b) its source, including its manufacturer, its 
country of manufacturing, its country of 
origin or its marketing authorisation holder; 
or 
(c) its history, including the records and 
documents relating to the distribution 
channels used.  
This definition does not include unintentional 
quality defects and is without prejudice to 
infringements of intellectual property rights.’;  
(2) in Article 2, paragraph 3 is replaced by the following:  
‘3. Notwithstanding paragraph 1 of this Article and 
Article 3(4), Title IV of this Directive shall apply to the 
manufacture of medicinal products intended only for 
export and to intermediate products, active substances 
and excipients.  
4. Paragraph 1 shall be without prejudice to Articles 
52b and 85a.’;  
(3) in Article 8(3), the following point is inserted:  
‘(ha) A written confirmation that the manufacturer of the 
medicinal product has verified compliance of the 
manufacturer of the active substance with principles 
and guidelines of good manufacturing practice by 
conducting audits, in accordance with point (f) of 
Article 46. The written confirmation shall contain 
a reference to the date of the audit and a declaration 
that the outcome of the audit confirms that the 
manufacturing complies with the principles and 
guidelines of good manufacturing practice.’;  
(4) in Article 40, paragraph 4 is replaced by the following:  
‘4. Member States shall enter the information relating to 
the authorisation referred to in paragraph 1 of this Article 
in the Union database referred to in Article 111(6).’;  
(5) in Article 46, point (f) is replaced by the following:  
‘(f) to comply with the principles and guidelines of good 
manufacturing practice for medicinal products and to 
use only active substances, which have been manu ­
factured in accordance with good manufacturing 
practice for active substances and distributed in 
accordance with good distribution practices for 
active substances. To this end, the holder of the 
manufacturing authorisation shall verify compliance 
by the manufacturer and distributors of active 
substances with good manufacturing practice and 
good distribution practices by conducting audits at 
the manufacturing and distribution sites of the manu ­
facturer and distributors of active substances. The holder of the manufacturing authorisation shall 
verify such compliance either by himself or, without 
prejudice to his responsibility as provided for in this 
Directive, through an entity acting on his behalf under 
a contract.  
The holder of the manufacturing authorisation shall 
ensure that the excipients are suitable for use in 
medicinal products by ascertaining what the appro ­
priate good manufacturing practice is. This shall be 
ascertained on the basis of a formalised risk 
assessment in accordance with the applicable 
guidelines referred to in the fifth paragraph of 
Article 47. Such risk assessment shall take into 
account requirements under other appropriate 
quality systems as well as the source and intended 
use of the excipients and previous instances of 
quality defects. The holder of the manufacturing auth ­
orisation shall ensure that the appropriate good 
manufacturing practice so ascertained, is applied. 
The holder of the manufacturing authorisation shall 
document the measures taken under this paragraph;  
(g) to inform the competent authority and the marketing 
authorisation holder immediately if he obtains 
information that medicinal products which come 
under the scope of his manufacturing authorisation 
are, or are suspected of being, falsified irrespective 
of whether those medicinal products were distributed 
within the legal supply chain or by illegal means, 
including illegal sale by means of information 
society services;  
(h) to verify that the manufacturers, importers or 
distributors from whom he obtains active substances 
are registered with the competent authority of the 
Member State in which they are established;  
(i) to verify the authenticity and quality of the active 
substances and the excipients.’;  
(6) the following Article is inserted:  
‘Article 46b  
1. Member States shall take appropriate measures to 
ensure that the manufacture, import and distribution on 
their territory of active substances, including active 
substances that are intended for export, comply with 
good manufacturing practice and good distribution 
practices for active substances.  
2. Active substances shall only be imported if the 
following conditions are fulfilled:  
(a) the active substances have been manufactured in 
accordance with standards of good manufacturing 
practice at least equivalent to those laid down by the 
Union pursuant to the third paragraph of Article 47; 
and 
(b) the active substances are accompanied by a written 
confirmation from the competent authority of the 
exporting third country of the following:EN L 174/78 Official Journal of the European Union 1.7.2011(i) the standards of good manufacturing practice 
applicable to the plant manufacturing the 
exported active substance are at least equivalent 
to those laid down by the Union pursuant to 
the third paragraph of Article 47;  
(ii) the manufacturing plant concerned is subject to 
regular, strict and transparent controls and to 
the effective enforcement of good manufacturing 
practice, including repeated and unannounced 
inspections, so as to ensure a protection of 
public health at least equivalent to that in the 
Union; and  
(iii) in the event of findings relating to non- 
compliance, information on such findings is 
supplied by the exporting third country to the 
Union without any delay.  
This written confirmation shall be without prejudice to the 
obligations set out in Article 8 and in point (f) of 
Article 46.  
3. The requirement set out in point (b) of paragraph 2 
of this Article shall not apply if the exporting country is 
included in the list referred to in Article 111b.  
4. Exceptionally and where necessary to ensure the 
availability of medicinal products, when a plant manufac ­
turing an active substance for export has been inspected 
by a Member State and was found to comply with the 
principles and guidelines of good manufacturing practice 
laid down pursuant to the third paragraph of Article 47, 
the requirement set out in point (b) of paragraph 2 of this 
Article may be waived by any Member State for a period 
not exceeding the validity of the certificate of Good Manu ­
facturing Practice. Member States that make use of the 
possibility of such waiver, shall communicate this to the 
Commission.’;  
(7) in Article 47, the third and fourth paragraphs are replaced 
by the following:  
‘The Commission shall adopt, by means of delegated acts 
in accordance with Article 121a and subject to the 
conditions laid down in Articles 121b and 121c, the prin ­
ciples and guidelines of good manufacturing practice for 
active substances referred to in the first paragraph of point 
(f) of Article 46 and in Article 46b.  
The principles of good distribution practices for active 
substances referred to in the first paragraph of point (f) 
of Article 46 shall be adopted by the Commission in the 
form of guidelines.  
The Commission shall adopt guidelines on the formalised 
risk assessment for ascertaining the appropriate good 
manufacturing practice for excipients referred to in the 
second paragraph of point (f) of Article 46.’;  
(8) the following Article is inserted:  
‘Article 47a  
1. The safety features referred to in point (o) of 
Article 54 shall not be removed or covered, either fully 
or partially, unless the following conditions are fulfilled:  (a) the manufacturing authorisation holder verifies, prior 
to partly or fully removing or covering those safety 
features, that the medicinal product concerned is 
authentic and that it has not been tampered with;  
(b) the manufacturing authorisation holder complies with 
point (o) of Article 54 by replacing those safety 
features with safety features which are equivalent as 
regards the possibility to verify the authenticity, identi ­
fication and to provide evidence of tampering of the 
medicinal product. Such replacement shall be 
conducted without opening the immediate packaging 
as defined in point 23 of Article 1.  
Safety features shall be considered equivalent if they:  
(i) comply with the requirements set out in the 
delegated acts adopted pursuant to Article 54a(2); 
and 
(ii) are equally effective in enabling the verification of 
authenticity and identification of medicinal 
products and in providing evidence of tampering 
with medicinal products;  
(c) the replacement of the safety features is conducted in 
accordance with applicable good manufacturing 
practice for medicinal products; and  
(d) the replacement of the safety features is subject to 
supervision by the competent authority.  
2. Manufacturing authorisation holders, including those 
performing the activities referred to in paragraph 1 of this 
Article, shall be regarded as producers and therefore held 
liable for damages in the cases and under the conditions 
set forth in Directive 85/374/EEC.’;  
(9) in Article 51(1), the following subparagraph is inserted 
before the second subparagraph:  
‘The qualified person referred to in Article 48 shall in the 
case of medicinal products intended to be placed on the 
market in the Union, ensure that the safety features 
referred to in point (o) of Article 54 have been affixed 
on the packaging.’;  
(10) the following Articles are inserted:  
‘Article 52a  
1. Importers, manufacturers and distributors of active 
substances who are established in the Union shall 
register their activity with the competent authority of the 
Member State in which they are established.  
2. The registration form shall include, at least, the 
following information:  
(i) name or corporate name and permanent address;  
(ii) the active substances which are to be imported, manu ­
factured or distributed;  
(iii) particulars regarding the premises and the technical 
equipment for their activity.EN 1.7.2011 Official Journal of the European Union L 174/793. The persons referred to in paragraph 1 shall submit 
the registration form to the competent authority at least 
60 days prior to the intended commencement of their 
activity.  
4. The competent authority may, based on a risk 
assessment, decide to carry out an inspection. If the 
competent authority notifies the applicant within 60 
days of the receipt of the registration form that an 
inspection will be carried out, the activity shall not begin 
before the competent authority has notified the applicant 
that he may commence the activity. If within 60 days of 
the receipt of the registration form the competent 
authority has not notified the applicant that an inspection 
will be carried out, the applicant may commence the 
activity.  
5. The persons referred to in paragraph 1 shall 
communicate annually to the competent authority an 
inventory of the changes which have taken place as 
regards the information provided in the registration 
form. Any changes that may have an impact on the 
quality or safety of the active substances that are manu ­
factured, imported or distributed must be notified 
immediately.  
6. Persons referred to in paragraph 1 who had 
commenced their activity before 2 January 2013 shall 
submit the registration form to the competent authority 
by 2 March 2013.  
7. Member States shall enter the information provided 
in accordance with paragraph 2 of this Article in the 
Union database referred to in Article 111(6).  
8. This Article shall be without prejudice to 
Article 111.  
Article 52b  
1. Notwithstanding Article 2(1), and without prejudice 
to Title VII, Member States shall take the necessary 
measures in order to prevent medicinal products that are 
introduced into the Union, but are not intended to be 
placed on the market of the Union, from entering into 
circulation if there are sufficient grounds to suspect that 
those products are falsified.  
2. In order to establish what the necessary measures 
referred to in paragraph 1 of this Article are, the 
Commission may adopt, by means of delegated acts in 
accordance with Article 121a, and subject to the 
conditions laid down in Articles 121b and 121c, 
measures supplementing paragraph 1 of this Article as 
regards the criteria to be considered and the verifications 
to be made when assessing the potential falsified character 
of medicinal products introduced into the Union but not 
intended to be placed on the market.’;  
(11) in Article 54, the following point is added:  
‘(o) for medicinal products other than radiophar ­
maceuticals referred to in Article 54a(1), safety 
features enabling wholesale distributors and persons 
authorised or entitled to supply medicinal products to 
the public to:  — verify the authenticity of the medicinal product, 
and 
— identify individual packs,  
as well as a device allowing verification of whether 
the outer packaging has been tampered with.’;  
(12) the following Article is inserted:  
‘Article 54a  
1. Medicinal products subject to prescription shall bear 
the safety features referred to in point (o) of Article 54, 
unless they have been listed in accordance with the 
procedure pursuant to point (b) of paragraph 2 of this 
Article.  
Medicinal products not subject to prescription shall not 
bear the safety features referred to in point (o) of 
Article 54, unless, by way of exception, they have been 
listed in accordance with the procedure pursuant to point 
(b) of paragraph 2 of this Article, after having been 
assessed to be at risk of falsification.  
2. The Commission shall adopt, by means of delegated 
acts in accordance with Article 121a and subject to the 
conditions laid down in Articles 121b and 121c, measures 
supplementing point (o) of Article 54 with the objective of 
establishing the detailed rules for the safety features 
referred to in point (o) of Article 54.  
Those delegated acts shall set out:  
(a) the characteristics and technical specifications of the 
unique identifier of the safety features referred to in 
point (o) of Article 54 that enables the authenticity of 
medicinal products to be verified and individual packs 
to be identified. When establishing the safety features 
due consideration shall be given to their cost-effec ­
tiveness;  
(b) the lists containing the medicinal products or product 
categories which, in the case of medicinal products 
subject to prescription shall not bear the safety 
features, and in the case of medicinal products not 
subject to prescription shall bear the safety features 
referred to in point (o) of Article 54. Those lists 
shall be established considering the risk of and the 
risk arising from falsification relating to medicinal 
products or categories of medicinal products. To this 
end, at least the following criteria shall be applied:  
(i) the price and sales volume of the medicinal 
product;  
(ii) the number and frequency of previous cases of 
falsified medicinal products being reported 
within the Union and in third countries and the 
evolution of the number and frequency of such 
cases to date;  
(iii) the specific characteristics of the medicinal 
products concerned;  
(iv) the severity of the conditions intended to be 
treated;  
(v) other potential risks to public health;EN L 174/80 Official Journal of the European Union 1.7.2011(c) the procedures for the notification to the Commission 
provided for in paragraph 4 and a rapid system for 
evaluating and deciding on such notification for the 
purpose of applying point (b);  
(d) the modalities for the verification of the safety features 
referred to in point (o) of Article 54 by the manu ­
facturers, wholesalers, pharmacists and persons auth ­
orised or entitled to supply medicinal products to the 
public and by the competent authorities. Those 
modalities shall allow the verification of the auth ­
enticity of each supplied pack of the medicinal 
products bearing the safety features referred to in 
point (o) of Article 54 and determine the extent of 
such verification. When establishing those modalities, 
the particular characteristics of the supply chains in 
Member States, and the need to ensure that the 
impact of verification measures on particular actors 
in the supply chains is proportionate, shall be taken 
into account;  
(e) provisions on the establishment, management and 
accessibility of the repositories system in which 
information on the safety features, enabling the verifi ­
cation of the authenticity and identification of 
medicinal products, as provided for in point (o) of 
Article 54, shall be contained. The costs of the reposi ­
tories system shall be borne by the manufacturing 
authorisation holders of medicinal products bearing 
the safety features.  
3. When adopting the measures referred to in 
paragraph 2, the Commission shall take due account of 
at least the following:  
(a) the protection of personal data as provided for in 
Union law;  
(b) the legitimate interests to protect information of a 
commercially confidential nature;  
(c) the ownership and confidentiality of the data generated 
by the use of the safety features; and  
(d) the cost-effectiveness of the measures.  
4. The national competent authorities shall notify the 
Commission of non-prescription medicinal products which 
they judge to be at risk of falsification and may inform the 
Commission of medicinal products which they deem not 
to be at risk according to the criteria set out in point (b) of 
paragraph 2 of this Article.  
5. Member States may, for the purposes of reim ­
bursement or pharmacovigilance, extend the scope of 
application of the unique identifier referred to in point 
(o) of Article 54 to any medicinal product subject to 
prescription or subject to reimbursement.  
Member States may, for the purposes of reimbursement, 
pharmacovigilance or pharmacoepidemiology, use the 
information contained in the repositories system referred 
to in point (e) of paragraph 2 of this Article.  
Member States may, for the purposes of patient safety, 
extend the scope of application of the anti-tampering device referred to in point (o) of Article 54 to any 
medicinal product.’;  
(13) in Article 57, the fourth indent of the first paragraph is 
replaced by the following:  
‘— authenticity and identification in accordance with 
Article 54a(5).’;  
(14) the heading of title VII is replaced by the following:  
‘Wholesale distribution and brokering of medicinal 
products’;  
(15) in Article 76, paragraph 3 is replaced by the following:  
‘3. Any distributor, not being the marketing authori ­
sation holder, who imports a medicinal product from 
another Member State shall notify the marketing authori ­
sation holder and the competent authority in the Member 
State to which the medicinal product will be imported of 
his intention to import that product. In the case of 
medicinal products which have not been granted an auth ­
orisation pursuant to Regulation (EC) No 726/2004, the 
notification to the competent authority shall be without 
prejudice to additional procedures provided for in the 
legislation of that Member State and to fees payable to 
the competent authority for examining the notification.  
4. In the case of medicinal products which have been 
granted an authorisation pursuant to Regulation (EC) No 
726/2004, the distributor shall submit the notification in 
accordance with paragraph 3 of this Article to the 
marketing authorisation holder and the Agency. A fee 
shall be payable to the Agency for checking that the 
conditions laid down in Union legislation on medicinal 
products and in the marketing authorisations are 
observed.’;  
(16) Article 77 is amended as follows:  
(a) paragraph 1 is replaced by the following:  
‘1. Member States shall take all appropriate 
measures to ensure that the wholesale distribution of 
medicinal products is subject to the possession of an 
authorisation to engage in activity as a wholesaler in 
medicinal products, stating the premises located on 
their territory for which it is valid.’;  
(b) paragraphs 4 and 5 are replaced by the following:  
‘4. Member States shall enter the information 
relating to the authorisations referred to in paragraph 
1 of this Article in the Union database referred to in 
Article 111(6). At the request of the Commission or 
any Member State, Member States shall provide all 
appropriate information concerning the individual 
authorisations which they have granted under 
paragraph 1 of this Article.  
5. Checks on the persons authorised to engage in 
activity as a wholesaler in medicinal products, and the 
inspection of their premises, shall be carried out under 
the responsibility of the Member State which granted 
the authorisation for premises located on its territory.’;EN 1.7.2011 Official Journal of the European Union L 174/81(17) Article 80 is amended as follows:  
(a) the following point is inserted:  
‘(ca) they must verify that the medicinal products 
received are not falsified by checking the safety 
features on the outer packaging, in accordance 
with the requirements laid down in the 
delegated acts referred to in Article 54a(2);’;  
(b) point (e) is replaced by the following:  
‘(e) they must keep records either in the form of 
purchase/sales invoices or on computer, or in 
any other form, giving for any transaction in 
medicinal products received, dispatched or 
brokered at least the following information:  
— date,  
— name of the medicinal product,  
— quantity received, supplied or brokered,  
— name and address of the supplier or consignee, 
as appropriate,  
— batch number of the medicinal products at 
least for products bearing the safety features 
referred to in point (o) of Article 54;’;  
(c) the following points are added:  
‘(h) they must maintain a quality system setting out 
responsibilities, processes and risk management 
measures in relation to their activities;  
(i) they must immediately inform the competent 
authority and, where applicable, the marketing 
authorisation holder, of medicinal products they 
receive or are offered which they identify as 
falsified or suspect to be falsified.’;  
(d) the following paragraphs are added:  
‘For the purposes of point (b), where the medicinal 
product is obtained from another wholesale 
distributor, wholesale distribution authorisation 
holders must verify compliance with the principles 
and guidelines of good distribution practices by the 
supplying wholesale distributor. This includes 
verifying whether the supplying wholesale distributor 
holds a wholesale distribution authorisation.  
Where the medicinal product is obtained from the 
manufacturer or importer, wholesale distribution auth ­
orisation holders must verify that the manufacturer or 
importer holds a manufacturing authorisation.  
Where the medicinal product is obtained through 
brokering, the wholesale distribution authorisation 
holders must verify that the broker involved fulfils 
the requirements set out in this Directive.’;  (18) in the first paragraph of Article 82, the following indent is 
added:  
‘— batch number of the medicinal products at least for 
products bearing the safety features referred to in 
point (o) of Article 54;’;  
(19) the following Articles are inserted:  
‘Article 85a  
In the case of wholesale distribution of medicinal products 
to third countries, Article 76 and point (c) of Article 80 
shall not apply. Moreover, points (b) and (ca) of Article 80 
shall not apply where a product is directly received from a 
third country but not imported. The requirements set out 
in Article 82 shall apply to the supply of medicinal 
products to persons in third countries authorised or 
entitled to supply medicinal products to the public.  
Article 85b  
1. Persons brokering medicinal products shall ensure 
that the brokered medicinal products are covered by a 
marketing authorisation granted pursuant to Regulation 
(EC) No 726/2004 or by the competent authorities of a 
Member State in accordance with this Directive.  
Persons brokering medicinal products shall have a 
permanent address and contact details in the Union, so 
as to ensure accurate identification, location, communi ­
cation and supervision of their activities by competent 
authorities.  
The requirements set out in points (d) to (i) of Article 80 
shall apply  mutatis mutandis  to the brokering of medicinal 
products.  
2. Persons may only broker medicinal products if they 
are registered with the competent authority of the Member 
State of their permanent address referred to in paragraph 
1. Those persons shall submit, at least, their name, 
corporate name and permanent address in order to 
register. They shall notify the competent authority of any 
changes thereof without unnecessary delay.  
Persons brokering medicinal products who had 
commenced their activity before 2 January 2013 shall 
register with the competent authority by 2 March 2013.  
The competent authority shall enter the information 
referred to in the first subparagraph in a register that 
shall be publicly accessible.  
3. The guidelines referred to in Article 84 shall include 
specific provisions for brokering.  
4. This Article shall be without prejudice to 
Article 111. Inspections referred to in Article 111 shall 
be carried out under the responsibility of the Member 
State where the person brokering medicinal products is 
registered.EN L 174/82 Official Journal of the European Union 1.7.2011If a person brokering medicinal products does not comply 
with the requirements set out in this Article, the 
competent authority may decide to remove that person 
from the register referred to in paragraph 2. The 
competent authority shall notify that person thereof.’;  
(20) the following Title is inserted before Title VIII:  
‘TITLE VIIA  
SALE AT A DISTANCE TO THE PUBLIC  
Article 85c  
1. Without prejudice to national legislation prohibiting 
the offer for sale at a distance of prescription medicinal 
products to the public by means of information society 
services, Member States shall ensure that medicinal 
products are offered for sale at a distance to the public 
by means of information society services as defined in 
Directive 98/34/EC of the European Parliament and of 
the Council of 22 June 1998 laying down a procedure 
for the provision of information in the field of technical 
standards and regulations and of rules on Information 
Society services (*) under the following conditions:  
(a) the natural or legal person offering the medicinal 
products is authorised or entitled to supply medicinal 
products to the public, also at a distance, in 
accordance with national legislation of the Member 
State in which that person is established;  
(b) the person referred to in point (a) has notified the 
Member State in which that person is established of 
at least the following information:  
(i) name or corporate name and permanent address 
of the place of activity from where those 
medicinal products are supplied;  
(ii) the starting date of the activity of offering 
medicinal products for sale at a distance to the 
public by means of information society services;  
(iii) the address of the website used for that purpose 
and all relevant information necessary to identify 
that website;  
(iv) if applicable, the classification in accordance with 
Title VI of the medicinal products offered for sale 
at a distance to the public by means of 
information society services.  
Where appropriate, that information shall be updated;  
(c) the medicinal products comply with the national legis ­
lation of the Member State of destination in 
accordance with Article 6(1);  
(d) without prejudice to the information requirements set 
out in Directive 2000/31/EC of the European 
Parliament and of the Council of 8 June 2000 on 
certain legal aspects of information society services, 
in particular electronic commerce, in the Internal 
Market (Directive on electronic commerce) (**), the 
website offering the medicinal products contains at 
least:  
(i) the contact details of the competent authority or 
the authority notified pursuant to point (b);  (ii) a hyperlink to the website referred to in paragraph 
4 of the Member State of establishment;  
(iii) the common logo referred to in paragraph 3 
clearly displayed on every page of the website 
that relates to the offer for sale at a distance to 
the public of medicinal products. The common 
logo shall contain a hyperlink to the entry of 
the person in the list referred to in point (c) of 
paragraph 4.  
2. Member States may impose conditions, justified on 
grounds of public health protection, for the retail supply 
on their territory of medicinal products for sale at a 
distance to the public by means of information society 
services.  
3. A common logo shall be established that is recog ­
nisable throughout the Union, while enabling the identifi ­
cation of the Member State where the person offering 
medicinal products for sale at a distance to the public is 
established. That logo shall be clearly displayed on 
websites offering medicinal products for sale at a 
distance to the public in accordance with point (d) of 
paragraph 1.  
In order to harmonise the functioning of the common 
logo, the Commission shall adopt implementing acts 
regarding:  
(a) the technical, electronic and cryptographic 
requirements for verification of the authenticity of 
the common logo;  
(b) the design of the common logo.  
Those implementing acts shall, where necessary, be 
amended to take account of technical and scientific 
progress. Those implementing acts shall be adopted in 
accordance with the procedure referred to in 
Article 121(2).  
4. Each Member State shall set up a website providing 
at least the following:  
(a) information on the national legislation applicable to 
the offering of medicinal products for sale at a 
distance to the public by means of information 
society services, including information on the fact 
that there may be differences between Member States 
regarding classification of medicinal products and the 
conditions for their supply;  
(b) information on the purpose of the common logo;  
(c) the list of persons offering the medicinal products for 
sale at a distance to the public by means of 
information society services in accordance with 
paragraph 1 as well as their website addresses;  
(d) background information on the risks related to 
medicinal products supplied illegally to the public by 
means of information society services.  
This website shall contain a hyperlink to the website 
referred to in paragraph 5.EN 1.7.2011 Official Journal of the European Union L 174/835. The Agency shall set up a website providing the 
information referred to in points (b) and (d) of 
paragraph 4, information on the Union legislation 
applicable to falsified medicinal products as well as 
hyperlinks to the Member States’ websites referred to in 
paragraph 4. The Agency’s website shall explicitly mention 
that the Member States’ websites contain information on 
persons authorised or entitled to supply medicinal 
products at a distance to the public by means of 
information society services in the Member State 
concerned.  
6. Without prejudice to Directive 2000/31/EC and the 
requirements set out in this Title, Member States shall take 
the necessary measures to ensure that other persons than 
those referred to in paragraph 1 that offer medicinal 
products for sale at a distance to the public by means of 
information society services and that operate on their 
territory are subject to effective, proportionate and 
dissuasive penalties.  
Article 85d  
Without prejudice to the competences of the Member 
States, the Commission shall, in cooperation with the 
Agency and Member State authorities, conduct or 
promote information campaigns aimed at the general 
public on the dangers of falsified medicinal products. 
Those campaigns shall raise consumer awareness of the 
risks related to medicinal products supplied illegally at a 
distance to the public by means of information society 
services and of the functioning of the common logo, the 
Member States’ websites and the Agency’s website.  
___________  
(*) OJ L 204, 21.7.1998, p. 37.  
(**) OJ L 178, 17.7.2000, p. 1.’;  
(21) Article 111 is amended as follows:  
(a) paragraph 1 is replaced by the following:  
‘1. The competent authority of the Member State 
concerned shall, in cooperation with the Agency, 
ensure that the legal requirements governing 
medicinal products are complied with, by means of 
inspections, if necessary unannounced, and, where 
appropriate, by asking an Official Medicines Control 
Laboratory or a laboratory designated for that 
purpose to carry out tests on samples. This coop ­
eration shall consist in sharing information with the 
Agency on both inspections that are planned and that 
have been conducted. Member States and the Agency 
shall cooperate in the coordination of inspections in 
third countries. The inspections shall include but not 
be limited to the ones mentioned in paragraphs 1a to 
1f. 
1a. Manufacturers, located in the Union or in third 
countries, and wholesale distributors of medicinal 
products shall be subject to repeated inspections.  
1b. The competent authority of the Member State 
concerned shall have a system of supervision including by inspections at an appropriate frequency based on 
risk, at the premises of the manufacturers, importers, 
or distributors of active substances, located on its 
territory, and effective follow-up thereof.  
Whenever it considers that there are grounds for 
suspecting non-compliance with the legal requirements 
laid down in this Directive, including the principles 
and guidelines of good manufacturing practice and 
good distribution practices referred to in point (f) of 
Article 46 and in Article 47, the competent authority 
may carry out inspections at the premises of:  
(a) manufacturers or distributors of active substances 
located in third countries;  
(b) manufacturers or importers of excipients.  
1c. Inspections referred to in paragraphs 1a and 1b 
may also be carried out in the Union and in third 
countries at the request of a Member State, the 
Commission or the Agency.  
1d. Inspections may also take place at the premises 
of marketing authorisation holders and of brokers of 
medicinal products.  
1e. In order to verify whether the data submitted in 
order to obtain a conformity certificate comply with 
the monographs of the European Pharmacopoeia, the 
standardisation body of the nomenclatures and the 
quality norms within the meaning of the Convention 
relating to the elaboration of the European Phar ­
macopoeia (the European Directorate for the Quality 
of Medicines and Healthcare) may ask the Commission 
or the Agency to request such an inspection when the 
starting material concerned is the subject of a 
European Pharmacopoeia monograph.  
1f. The competent authority of the Member State 
concerned may carry out inspections of starting 
material manufacturers at the specific request of the 
manufacturer.  
1g. Inspections shall be carried out by officials 
representing the competent authority who shall be 
empowered to:  
(a) inspect the manufacturing or commercial estab ­
lishments of manufacturers of medicinal products, 
of active substances or of excipients, and any 
laboratories employed by the holder of the manu ­
facturing authorisation to carry out checks 
pursuant to Article 20;  
(b) take samples including with a view to independent 
tests being carried out by an Official Medicines 
Control Laboratory or a laboratory designated for 
that purpose by a Member State;  
(c) examine any documents relating to the object of 
the inspection, subject to the provisions in force in 
the Member States on 21 May 1975 placing 
restrictions on these powers with regard to the 
description of the manufacturing method;EN L 174/84 Official Journal of the European Union 1.7.2011(d) inspect the premises, records, documents and phar ­
macovigilance system master file of the marketing 
authorisation holder or any firms employed by the 
marketing authorisation holder to perform the 
activities described in Title IX.  
1h. Inspections shall be carried out in accordance 
with the guidelines referred to in Article 111a.’;  
(b) paragraphs 3 to 6 are replaced by the following:  
‘3. After every inspection as referred to in 
paragraph 1, the competent authority shall report on 
whether the inspected entity complies with the prin ­
ciples and guidelines of good manufacturing practice 
and good distribution practices referred to in Articles 
47 and 84, as applicable, or on whether the marketing 
authorisation holder complies with the requirements 
laid down in Title IX.  
The competent authority which carried out the 
inspection shall communicate the content of those 
reports to the inspected entity.  
Before adopting the report, the competent authority 
shall give the inspected entity concerned the oppor ­
tunity to submit comments.  
4. Without prejudice to any arrangements which 
may have been concluded between the Union and 
third countries, a Member State, the Commission or 
the Agency may require a manufacturer established in 
a third country to submit to an inspection as referred 
to in this Article.  
5. Within 90 days of an inspection as referred to in 
paragraph 1, a certificate of good manufacturing 
practice or good distribution practices shall, when 
applicable, be issued to the inspected entity if the 
outcome of the inspection shows that it complies 
with the principles and guidelines of good manufac ­
turing practice or good distribution practices as 
provided for by Union legislation.  
If inspections are performed as part of the certification 
procedure for the monographs of the European Phar ­
macopoeia, a certificate shall be drawn up.  
6. Member States shall enter the certificates of good 
manufacturing practice and good distribution practices 
which they issue in a Union database managed by the 
Agency on behalf of the Union. Pursuant to 
Article 52a(7), Member States shall also enter 
information in that database regarding the registration 
of importers, manufacturers and distributors of active 
substances. The database shall be publicly accessible.’;  
(c) paragraph 7 is amended as follows:  
(i) the words ‘paragraph 1’ are replaced by the words 
‘paragraph 1g’;  
(ii) the words ‘used as starting materials’ are deleted;  (d) in the first subparagraph of paragraph 8, the words 
‘paragraph 1(d)’ are replaced by the words ‘point (d) of 
paragraph 1g’;  
(22) the following Articles are inserted:  
‘Article 111a  
The Commission shall adopt detailed guidelines laying 
down the principles applicable to inspections referred to 
in Article 111.  
Member States shall, in cooperation with the Agency, 
establish the form and content of the authorisation 
referred to in Articles 40(1) and 77(1), of the reports 
referred to in Article 111(3), of the certificates of good 
manufacturing practice and of the certificates of good 
distribution practices referred to in Article 111(5).  
Article 111b  
1. At the request of a third country, the Commission 
shall assess whether that country’s regulatory framework 
applicable to active substances exported to the Union and 
the respective control and enforcement activities ensure a 
level of protection of public health equivalent to that of 
the Union. If the assessment confirms such equivalence, 
the Commission shall adopt a decision to include the third 
country in a list. The assessment shall take the form of a 
review of relevant documentation and, unless 
arrangements as referred to in Article 51(2) of this 
Directive are in place that cover this area of activity, that 
assessment shall include an on-site review of the third 
country’s regulatory system and, if necessary, an 
observed inspection of one or more of the third 
country’s manufacturing sites for active substances. In 
the assessment particular account shall be taken of:  
(a) the country’s rules for good manufacturing practice;  
(b) the regularity of inspections to verify compliance with 
good manufacturing practice;  
(c) the effectiveness of enforcement of good manufac ­
turing practice;  
(d) the regularity and rapidity of information provided by 
the third country relating to non-compliant producers 
of active substances.  
2. The Commission shall adopt the necessary imple ­
menting acts to apply the requirements set out in points 
(a) to (d) of paragraph 1 of this Article. Those imple ­
menting acts shall be adopted in accordance with the 
procedure referred to in Article 121(2).  
3. The Commission shall verify regularly whether the 
conditions laid down in paragraph 1 are fulfilled. The 
first verification shall take place no later than 3 years 
after the country has been included in the list referred to 
in paragraph 1.EN 1.7.2011 Official Journal of the European Union L 174/854. The Commission shall perform the assessment and 
verification referred to in paragraphs 1 and 3 in coop ­
eration with the Agency and the competent authorities 
of the Member States.’;  
(23) in Article 116, the following paragraph is added:  
‘The second paragraph of this Article also applies in cases 
where the manufacture of the medicinal product is not 
carried out in compliance with the particulars provided 
pursuant to point (d) of Article 8(3), or where controls 
are not carried out in compliance with the control 
methods described pursuant to point (h) of Article 8(3).’;  
(24) the following Article is inserted:  
‘Article 117a  
1. Member States shall have a system in place which 
aims at preventing medicinal products that are suspected 
to present a danger to health from reaching the patient.  
2. The system referred to in paragraph 1 shall cover the 
receipt and handling of notifications of suspected falsified 
medicinal products as well as of suspected quality defects 
of medicinal products. The system shall also cover recalls 
of medicinal products by marketing authorisation holders 
or withdrawals of medicinal products from the market 
ordered by national competent authorities from all 
relevant actors in the supply chain both during and 
outside normal working hours. The system shall also 
make it possible to recall, where necessary with the 
assistance of health professionals, medicinal products 
from patients who received such products.  
3. If the medicinal product in question is suspected of 
presenting a serious risk to public health, the competent 
authority of the Member State in which that product was 
first identified shall, without any delay, transmit a rapid 
alert notification to all Member States and all actors in the 
supply chain in that Member State. In the event of such 
medicinal products being deemed to have reached patients, 
urgent public announcements shall be issued within 24 
hours in order to recall those medicinal products from 
the patients. Those announcements shall contain sufficient 
information on the suspected quality defect or falsification 
and the risks involved.  
4. Member States shall by 22 July 2013 notify the 
Commission of the details of their respective national 
systems referred to in this Article.’;  
(25) the following Articles are inserted:  
‘Article 118a  
1. The Member States shall lay down the rules on 
penalties applicable to infringements of the national 
provisions adopted pursuant to this Directive and shall 
take all necessary measures to ensure that those penalties 
are implemented. The penalties must be effective, propor ­
tionate and dissuasive.  Those penalties shall not be inferior to those applicable to 
infringements of national law of similar nature and 
importance.  
2. The rules referred to in paragraph 1 shall address, 
inter alia, the following:  
(a) the manufacturing, distribution, brokering, import and 
export of falsified medicinal products, as well as the 
sale of falsified medicinal products at a distance to the 
public by means of information society services;  
(b) non-compliance with the provisions laid down in this 
Directive on manufacturing, distribution, import and 
export of active substances;  
(c) non-compliance with the provisions laid down in this 
Directive on the use of excipients.  
Where relevant, the penalties shall take into account the 
risk to public health presented by the falsification of 
medicinal products.  
3. The Member States shall notify the national 
provisions adopted pursuant to this Article to the 
Commission by 2 January 2013 and shall notify any 
subsequent amendment of those provisions without delay.  
By 2 January 2018, the Commission shall submit a report 
to the European Parliament and to the Council giving an 
overview of the transposition measures of Member States 
as regards this Article, together with an evaluation of the 
effectiveness of those measures.  
Article 118b  
Member States shall organise meetings involving patients 
“and consumers” organisations and, as necessary, Member 
States’ enforcement officers, in order to communicate 
public information about the actions undertaken in the 
area of prevention and enforcement to combat the falsifi ­
cation of medicinal products.  
Article 118c  
Member States, in applying this Directive, shall take the 
necessary measures to ensure cooperation between 
competent authorities for medicinal products and 
customs authorities.’;  
(26) in Article 121a(1), the words ‘Article 22b’ are replaced by 
the words ‘Articles 22b, 47, 52b and 54a’;  
(27) in Article 121b(1), the words ‘Article 22b’ are replaced by 
the words ‘Articles 22b, 47, 52b and 54a’;  
Article 2  
1. Member States shall bring into force the laws, regulations 
and administrative provisions necessary to comply with this 
Directive by 2 January 2013. They shall forthwith inform the 
Commission thereof.  
2. Member States shall apply those measures from 
2 January 2013.EN L 174/86 Official Journal of the European Union 1.7.2011However, the Member States shall apply:  
(a) the provisions necessary to comply with point 6 of 
Article 1 of this Directive in so far as it relates to 
Article 46b(2)(b) and Article 46b(3) and (4) of Directive 
2001/83/EC as inserted by this Directive from 2 July 2013;  
(b) the provisions necessary to comply with points 8, 9, 11 and 
12 of Article 1 of this Directive from 3 years after the date 
of publication of the delegated acts referred to in point 12 
of Article 1 of this Directive.  
Nevertheless, Member States which, on 21 July 2011, have 
systems in place for the purpose referred to in point 11 of 
Article 1 of this Directive shall apply the provisions 
necessary to comply with points 8, 9, 11 and 12 of 
Article 1 of this Directive at the latest from 6 years after 
the date of application of the delegated acts referred to in 
point 12 of Article 1 of this Directive;  
(c) the provisions necessary to comply with point 20 of 
Article 1 of this Directive in so far as it relates to 
Article 85c of Directive 2001/83/EC as inserted by this 
Directive at the latest from 1 year after the date of publi ­
cation of the implementing acts referred to in Article 85c(3) 
as inserted by this Directive.  
3. When Member States adopt the measures referred to in 
paragraph 1, they shall contain a reference to this Directive or 
be accompanied by such a reference on the occasion of their 
official publication. The methods of making such references 
shall be laid down by Member States.  
4. Member States shall communicate to the Commission the 
text of the main provisions of national law which they adopt in 
the field covered by this Directive.  
Article 3  
At the latest 5 years after the date of application of the 
delegated acts referred to in Article 54a(2) of Directive 
2001/83/EC as inserted by this Directive, the Commission 
shall submit a report to the European Parliament and to the 
Council containing the following:  
(a) a description, where possible including quantitative data, of 
the trends in the falsification of medicinal products in terms 
of: categories of medicinal products affected, distribution 
channels including sale at a distance to the public by 
means of information society services, the Member States 
concerned, the nature of the falsifications, and the regions 
of provenance of these products; and  (b) an evaluation of the contribution of the measures provided 
for in this Directive regarding the prevention of the entry of 
falsified medicinal products in the legal supply chain. That 
evaluation shall in particular assess point (o) of Article 54 
and Article 54a of Directive 2001/83/EC as inserted by this 
Directive.  
Article 4  
In order to adopt the delegated acts referred to in Article 54a(2) 
of Directive 2001/83/EC as inserted by this Directive, the 
Commission shall perform a study assessing at least the 
following aspects:  
(a) the technical options for the unique identifier of the safety 
features referred to in point (o) of Article 54 of Directive 
2001/83/EC as inserted by this Directive;  
(b) the options for the extent and the modalities of verification 
of the authenticity of the medicinal product bearing the 
safety features. This assessment shall take into account the 
particular characteristics of the supply chains in the Member 
States;  
(c) the technical options for establishing and managing the 
repositories system, referred to in point (e) of 
Article 54a(2) of Directive 2001/83/EC as inserted by this 
Directive.  
The study shall, for each of the options, assess benefits, costs 
and cost-effectiveness.  
Article 5  
This Directive shall enter into force on the 20th day following 
its publication in the  Official Journal of the European Union . 
Article 6  
This Directive is addressed to the Member States.  
Done at Strasbourg, 8 June 2011.  
For the European Parliament 
The President  
J. BUZEK  For the Council 
The President  
GY ŐRI E.EN 1.7.2011 Official Journal of the European Union L 174/87