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Annual Report 2017

Words from the President
Dr Gesine Klein
Towards sustainable standards:
the global context

Activity report 2017
Towards sustainable standards

Setting pharmaceutical standards
for homeopathic preparations in
the European Pharmacopoeia

Regulatory environment
Quality and safety:
working with HMPWG

Our sector
Joining the debate


Map of ECHAMP members

At a crossroads: complementary
Words from the President medicine and its medicines
The situation
Dr Gesine Klein of market
Globalisation is advancing in rapid strides, manifest in

public discussion. Complementary medicine systems are access for these
Towards no exception: homeopathy, anthroposophic medicine, medicines is not
Ayurveda, traditional Chinese medicine and acupuncture yet satisfactory.
sustainable are all attracting interest from patients, doctors, practi-
tioners and health institutions around the world.
standards: the The emerging economies of the BRICS countries,
specifically Brazil, India and China, are playing a leading
global context role in this respect. In Europe, Switzerland is moving
ahead in a systematic way.
“Continued dialogue is needed For Europe’s citizens and for its industry, the question is:
to create balanced regulation To what extent is the European Economic Area
that works in an increasingly committed to upholding its own traditions,
homeopathy and anthroposophic medicine ?
global context.”
• How far do European patients have freedom of choice
of therapy while being guaranteed a maximum level Dr Gesine Klein,
of safety ? President,
• To what extent is there a common market for homeo-
pathic and anthroposophic medicinal products ?
• How strong is the European home base of homeopathy
and anthroposophic medicine when faced with global
competition of therapies ?
For ECHAMP and its member companies comes the
additional vital question:
How far is the integration of homeopathic and
anthroposophic medicines in Europe supported by
an appropriate regulatory base for market access ?
The 2017 report by the Homeopathic Medicinal Products
Working Group (HMPWG) on the regulatory status of
homeopathic medicinal products (see page 4) shows a
highly diverse picture of the regulatory and market
situation of these medicinal products. The facts it pre-
sents complement the findings of ECHAMP’s 2013
report, The Availability of Homeopathic and Anthroposophic
Medicinal Products in the EU: the situation of market access
for these medicines is not yet satisfactory. ➝

— The EU goal of guaranteeing quality, safety and effective- Without sufficient dialogue, the risk is top down regula-
A constructive ness of homeopathic and anthroposophic medicines can tion, unworkable in the real world and downgraded
dialogue with only be met if workable and sustainable standards balance authority of the agencies, undermining the results of
the needs of the state (regulators) with the reality of the regulatory investments. Failure to achieve a good balance
competent and market (industry), prescribers and users. Otherwise between state regulators, industry and patients can result
empowered regulations will hinder the position of EU-based industries in overregulation, either leading to lack of availability and
bodies of and their services. a black market, or favouring monopolist industry.

regulators will All stakeholders seem to share the perception that im- True consensus is not easy. Every change of quality control
provements are necessary and all, including the EU parameters has an economic impact on industry. Good
be essential to institutions, the 28 Member States and the providers will, discipline, a robust process and transparent decision
proceed. of products and services, share a responsibility to find making will be required, as will a thorough understanding
solutions. of the sector by regulators.
In 2017, ECHAMP and its members continued to work at This will allow the sector to grow and develop, so that it
different levels to improve this situation, investing can take its place side by side with other complementary
considerable resources into the development of sustaina- medicine therapies, ensuring the continued availability of
ble standards. Solutions for the issues addressed high quality medicines and their therapies for the patients
are within the competence of the bodies of the EU and who want them.
Member States and of the European Pharmacopoiea.
To achieve progress, a well-structured, constructive
dialogue is essential.
It is a joint challenge to develop coherent, sustainable
standard setting that better balances public health require-
ments with market needs. A constructive dialogue with
competent and empowered bodies of regulators will be
essential to progress. Only in this way can we achieve a
consensus in the sector that can be acknowledged as
rational and consistent.

2 echamp annual report 2017

Photographer: Thomas Neu Picture provided by Dr. Reckeweg
echamp annual report 2017
In 2017, ECHAMP and its members invested consi- Six Member States refer to outstanding or open renewal, review
Activity report 2017 derable resources into the development of sustainable or assessment processes related to homeopathic medicinal
– standards to improve market access for homeopathic products. Only two EU Member States mention major
and anthroposophic medicinal products. obstacles for registration; however, significantly, the
Towards agency in France, the major market for homeopathic
Forum on national and medicinal products in the EU1, addresses the limitation of
sustainable global regulation
resources for dossier evaluation within the agency. Italy,
the third largest EU market, shows itself at the beginning
standards In February 2017, ECHAMP took part in the Global Forum of a review process and Spain, the fourth biggest, did not
in Delhi, organised by the World Integrated Medicine respond to the survey. This situation can only raise doubts
Strong and solution-oriented Forum, co-hosted by the Indian Ministry of Ayurveda, regarding the functioning of the regulatory system for
partners are needed to endorse Yoga, Unani, Siddha and Homoeopathy (AYUSH) and homeopathic medicinal products and the reasons for this.
opened by the Minister of State for AYUSH, Sh. Sripad Mutual recognition and decentralised procedures make no
the European homeopathic sector Yesso Naik. Its purpose was to discuss how to balance relevant contribution to the registration figures.
in a global market. the increasing and legitimate demand for homeopathic The approval situation for anthroposophic medicinal products is
products against the need for a regulatory framework that also divergent. Nearly half the responding EU Member
adequately addresses quality, safety and effectiveness. States approve these products, clearly demonstrating an
This two-day conference, which brought together 50 existing European tradition, although it is not clear to
delegates from 25 countries, set a unique global context which extent these approvals also cover the non-homeo-
for discussion. pathically produced anthroposophic medicinal products.
Only about half of these Member States provide an
HMPWG report: regulatory status appropriate labelling indicating the therapeutic framework
of homeopathic medicinal products for the use of these products. From industry’s perspective,
the established European tradition of anthroposophic
A new report from the Homeopathic Medicinal Products medicine is not yet reflected by an appropriate legal
Working Group (HMPWG), The Regulatory Status of framework supporting adequate approval procedures.
Homeopathic Medicinal Products for Human Use in the EU and
EF TA countries, published in 2017, provides a reliable insight HMWPG’s report, published 25 years after the first
into the situation for market access in Europe, reinforcing Directive for homeopathic medicinal products2, makes
a familiar story. ECHAMP’s analysis of this report con- a valuable contribution to transparency for agencies and
firms that the status of implementation of the EU approval companies. It provides a highly heterogeneous picture
procedures for homeopathic medicinal products differs within the EU. ECHAMP’s analysis shows no correlation
widely between Member States. between the availability of approved homeopathic medici-
nal products and the status of demand as indicated by
24 EU Member States responded to the survey; of these, sales data or prescriber figures3. The availability of
homeopathic medicinal products are marketed in 22 anthroposophic medicinal products is impaired by
countries. While these states all have a certain number of inappropriate approval procedures.
approved homeopathic medicinal products, their regulato-
ry status may differ. The number of approved homeopathic
medicinal products differs dramatically between just a few
and more than 3,000 approvals. –
1 Profile of an Industry, ECHAMP 2015
2 Directive 92/73/EEC
3 Profile of an Industry, ECHAMP 2015

4 echamp annual report 2017

The picture provided by HMPWG’s report complements In addition, ECHAMP’s technical experts have been Availability of mercury for homeopathic
ECHAMP’s findings, presented in its 2013 report, The working in depth for the last two years on the remaining
Availability of Homeopathic and Anthroposophic Medicinal problems. They have developed a list of fourteen additional and anthroposophic medicinal products
Products in the EU: ‘focus points’ elaborating the problems, their relevance to In 2017, ECHAMP and some of its members worked with
• In various Member States the availability of these industry and to ECHAMP’s goals. These have been divided other associations to secure the future import and export
medicinal products is threatened by the lack of registra- into two categories: of mercury and its compounds, a starting material for
tion, or by an incomplete or outstanding • five focus points where the competence to initiate a certain commonly prescribed homeopathic and anthropos-
re-registration process. solution is seen to be in the hands of the European ophic medicinal products. The high level of dilution used
Commission; in these products means there is no environmental impact
• The availability of homeopathic and anthroposophic of the use of this substance in this way.
medicinal products for OTC- or self-medication is • nine remaining focus points for which the EU Member
limited by incomplete implementation and execution States or their regulatory agencies hold the competence New EU legislation, originating in the United Nations’
of Article 16.2 of Directive 2001/83/EC. for the solution. Minamata Convention, a global treaty to protect human
health and the environment, was at risk of having an
• The availability of non-homeopathically produced Both routes of discussion require strong and solution-ori- unintentional but important impact on our industry.
anthroposophic medicinal products is limited due ented partners on the institutional side to endorse the
to the lack of legal provisions in the EU. European homeopathic sector in a global context. As a result of these efforts, the import into the EU of
mercury and of certain mixtures of mercury for the
• In many Member States the demand expressed in As a result of a dialogue with the European Commission, production of homeopathic or anthroposophic medicinal
terms of the numbers of homeopathic prescribers initiated in 2015, and as advised by the Health products will now be permitted; however, the export
is not reflected in the numbers of registrations. Commissioner, Vytenis Andriukaitis, we have favoured a outside the EU of mercury is broadly prohibited. Finished
The situation of market access for these medicines is bottom-up approach within the existing legal framework. homeopathic and anthroposophic medicinal products will
not yet satisfactory. In 2017, proposals for solutions were submitted to the not be affected.
Commission for the five focus points where the compe-
ECHAMP hopes that the survey will encourage and tence for the initiation of solution is in the hands of the ECHAMP thanks its members and partners whose
facilitate the sharing of best practice between agencies, European Commission. There is a need for discussion at a contribution and amendments helped secure the future
particularly with regards to proportionate regulation and technical level with the pragmatic attitude which seems to of these products.
availability of these medicinal products. characterize President Juncker’s Commission.
In order to achieve progress on the nine remaining focus
Improving market access points, those in the competence of the Member States,
For many years, ECHAMP members have worked to ECHAMP needs an institutional partner with which to
develop a list of practical regulatory and legal problems explore possible solutions. The problems, our need for
which hinder the daily regulatory work and market access solution and their relevance have been identified, but the
for their products. solutions cannot be developed without collaboration
At the forefront are two topics that require the elaboration with our counterparts at national level, the Member
of a solid scientific foundation, together with the scientific State agencies. In 2017, an informal meeting with repre-
stakeholders in the sector. These are the need for a sentatives of the Austrian Medicinal Agency (AGES)
solution, firstly for homeopathic and anthroposophic was encouraging.
medicinal products not under the scope of the simplified
registration4 scheme and secondly for the non-homeo-
pathic anthroposophic medicinal products. For both,
ECHAMP is involved in a long-term approach
to standard setting. –
4 Article 14 of Directive 2001/83/EC

echamp annual report 2017 5

In 2017, ECHAMP member companies continued their and the work of the homeopathic working groups on
efforts to contribute to a solution on harmonised quality quality control and manufacture, the companies have been
Setting control criteria for homeopathic medicinal products. working hard on improving their analytical and manufac-
Industry experts from France, Germany and Italy met to turing methods. In 2017, ECHAMP sent comments to
pharmaceutical explore common ground and inter-laboratory tests were Pharmeuropa consultations for Digitalis for homoeopathic
carried out. preparations, Sodium sulfate, anhydrous and Potassium
standards for sulfate, anhydrous.
An emerging opportunity
homeopathic for further development Sustainability
preparations in The broader context is a growing understanding of The European Pharmacopoeia has a growing global
impact. 69 countries worldwide are implementing the
different medicinal systems and their appropriate quality
the European standards. Within EDQM, both the Homoeopathic Raw WHO policy on the therapeutic approaches commonly
referred to as ‘traditional and complementary medicine’
Materials and Stocks Working Party and the Traditional
Pharmacopoeia Chinese Medicines Working Party are considering ap- (T&CM), which include homeopathic and anthroposophic
medicinal products. However, in order for users and
proaches to quality control. The related discussion of
producers worldwide to benefit from the Ph.Eur. standards
A real opportunity is emerging analytical markers and their implementation in quality
for these medicines, the quality criteria must be
control practice is also taking place in scientific literature1.
for further development of A key discussion point relates to the option of including sustainable.
quality criteria related to these high precision thin layer chromatography (HPTLC). A further dimension to the issue of sustainability has been
medicinal products. To be implemented, tools are needed to allow case to case clarified by the United Nations in its Agenda for
decision making. At the Global Forum organised by the Sustainable Development. Goal 12, ‘Sustainable consump-
World Integrated Medicine Forum in New Delhi in tion and production patterns’, refers to efficient use of
February, ECHAMP presented aspects to approach natural resources, sound management of chemicals,
rational decision making. In addition, EDQM has pub- reduction in waste generation and greater harmony with
lished some new general monographs, such as 2.8.25, nature. ECHAMP supports these goals and believes they
which concerns HPTLC, reflecting the need for a stand- should underpin all our work.
ardised methodology in Ph.Eur.
An additional angle to this debate was introduced by A busy 2018
EDQM2, when it stated that economic aspects relating to Even though it will not be easy, nor immediately accessible,
assays are currently under discussion. Although cost a real opportunity is emerging for further development of
criteria should not jeopardise the quality quality criteria related to homeopathic and anthroposophic
of medicinal products, ECHAMP welcomes the inclusion medicinal products. A thorough and disciplined dialogue
of this angle in the debate. Neglecting this point will cause will enable progress towards a common understanding of
industry monopolies and deindustrialisation and enhance conformity to established rules and shared beliefs and thus
grey markets with products of doubtful quality. to mutual consent.
1 Länger R. Stöger E, Kubelka W,
In 2017, EDQM continued to allocate substantial resources Let us roll up our sleeves and, step by step, progress. 
Helliwell K. (2017) Quality Standards for to our sector, making a valuable contribution to the sector
Herbal Drugs and Herbal Drug Preparations
– Appropriate or Improvements Necessary?
as a whole: the process to include further manufacturing
Planta Med 2017. methods continues and monographs of stocks are being
2 Bonn, September 2017 revised. This confirms EDQM as a solid and far-sighted
entrepreneur of its tasks. Encouraged by EDQM’s steps
6 echamp annual report 2017

In order for
users and
worldwide to
benefit from
the Ph.Eur.
for these
the quality
criteria must
be sustainable.

echamp annual report 2017 7

In 2017, ECHAMP and its members continued to engage commented, and even then only in part. The third list of

Quality and in work to foster harmonisation, by defining appropriate

standards for the quality and safety of homeopathic
first safe dilutions, still to be adopted, includes 36 sub-
stances. ECHAMP prepared comments for 12 substances.

safety: working medicinal products in the EU and submitting comments

to HMPWG consultations where possible. We thank our
The FSD debate
Our main comment again challenged the sources used for
with HMPWG members for their hard work and careful contributions.
We see from the publication of frequently asked questions,
the calculation of the first safe dilution: mean intakes per
day used as the acceptable daily amount were adequate for
We need constructive dialogue and appreciate, that it is HMPWG’s intention to pick the majority of infants less than six months old. This is not
up the open issues they have identified in the dossiers
with key decision makers on through their work; this is a clear sign that they acknowl-
a suitable basis for toxicological calculations and therefore
not for the calculation of first safe dilution. Appropriate
technical issues. edge the need for improvement. However, only in rare sources would be papers dealing with tolerable upper
instances was industry’s perspective taken into account intake levels. On the other hand, for some plants, the
and once again, the year just gone brought only an in- whole plant was used as the calculation basis, even in cases
creased regulatory burden on this sector. Nevertheless, where the toxicologically relevant components — second-
determined to improve the situation, and keen and ary metabolites — are known. It is not appropriate to use
committed to enter into constructive dialogue with key the whole plant as the basis for calculation, but a much
decision makers on technical issues, we will continue to smaller amount, even if no substance specific data is
share our expertise in 2018 and hope that it will bring available.
greater transparency.
In addition, HMPWG insists on what it calls the ‘most
conservative approach’, to ensure a high level of safety for
First safe dilutions all patient groups. Its calculation is based on the unrealis-
The trend towards high first safe dilutions continues. tic criteria of 10g or 10ml of a homoeopathic medicinal
To date, HMPWG has released three lists of first safe product daily with a lifelong body weight of 3 kg (the latter
dilutions (FSDs) for homeopathic medicines – the second represents an extremely critical condition just a few weeks
and third lists were adopted for consultation in 2017. The after birth).
first and second lists have been published and the third list Finally, on the one hand, the HMPWG approach is useful
was still under consideration at the end of 2017. Experience for products with potencies higher than the calculated and
shows that few of ECHAMP’s comments are taken into listed FSDs; on the other, it substantially increases the
consideration. burden of proof for products with potencies between
The second list of first safe dilutions includes 52 substanc- mother tincture and the respective listed FSD.
es. ECHAMP submitted comments on 37 substances This debate touches on the critical question: how to
(minerals and metals); the list was adopted in June 2017. adequately address the safety or the risk of homeopathic
HMPWG rejected ECHAMP’s recommendation to use as medicines? How thick must the safety net be to protect the
reference the ICH Guideline Q3D on elemental impurities patient? The EU legislator provides a hint, by defining the
which establishes Permitted Daily Exposures, considered limit for simplified registration according to Article 14 of
to be ‘protective of public health for all patient popula- Directive 2001/83/EC with more than one part per 10,000 of
tions’. This would have rated the first safe dilution for the mother tincture as a sufficient degree of dilution to
many minerals and metals one or two potency levels lower guarantee safety. The approach towards higher potencies
than those given by HMPWG. Our comments were seems to undermine this 1:10,000 rule which loses its
accepted on only 11 of the 37 substances on which we meaning if an FSD calculation is always required for an

8 echamp annual report 2017

— application under Article 14, whether or not the product Microbial limits
The trend contains less than or equal to 1:10,000 of a mother HMPWG’s Points to Consider document, adopted in June
towards high tincture. 2017, addresses the selection of microbial limits for
first safe Other views are possible as the practice in one EU Member non-sterile homeopathic raw materials, stocks, prepara-
State demonstrates. There, Article 14 is applied strictly tions and products. The new requirement that the microbi-
dilutions according to the law: products containing homeopathic al limit for aqueous preparations should be applied to
continues. preparations made of stocks from vegetal origin, equal to ethanolic dilutions will cause further difficulties for
or less concentrated than 1:10,000 of the mother tincture, manufacturers. For decades, homeopathic manufacturers
do not need further FSD or safety calculations (and have been performing microbial testing on the prepara-
therefore no Module 2.4 /4) unless the intention is to tions in accordance with specifications based on the
register a potency more concentrated than 1:10,000 of the European Pharmacopoeia. Agencies have accepted these
mother tincture. In this case, the safety has to be proven by specifications in thousands of registrations. There is no
the FSD calculation (included in Module 2.4 /4). For new scientific evidence. Homeopathic medicine manufac-
products with homeopathic preparations made of stocks turers need to be able to rely on established test specifica-
from chemical or mineral origin, for which by definition tions to avoid costly variations or even new stability
there is no mother tincture, safety has to be proven by the studies.
FSD calculation. Moreover, if in a Module 2.4/4 it can be
proven that a calculated FSD is below D4, registration EMA: identification of
according to Article 14 is possible, because there is a
sufficient degree of dilution to guarantee the safety of the medicinal products
medicinal product. In ECHAMP’s view, this Member ECHAMP has been granted a seat as an observer to the
State’s approach presents a counterpoint worthy of further EMA meeting of the Task Force for the Implementation
exploration, in order to limit the administrative burden of International Standards on Identification of Medicinal
linked to the simplified registration. Products in the EU (EU IDMP/SPOR Task Force). Our
participation is important to monitor and influence the
Quality electronic representation of data concerning homeopathic
and anthroposophic medicinal products.
Additional requirements for quality, published in 2017,
cause serious issues for ECHAMP’s members.
Suppliers of raw material
In February 2017, HMWPG issued a draft ‘Question &
Answers’ document addressing quality of raw material for
homeopathic products. The requirement in Question 2 to
name suppliers of plant material in the dossiers will cause
additional unnecessary work and an economic burden due
to the resulting need for many variations. This is because
most homeopathic preparations are manufactured from
fresh plants. If a crop fails the supplier must be changed
quickly. It is not possible to wait for the acceptance of a
new supplier because the supply has to be immediately
processed. ECHAMP recommends that it should be
possible to add a list of accepted suppliers into the dossier.
echamp annual report 2017 9
Homeopathy is the subject of much public debate, All questions answered
sometimes quite contentious and often with global
Our sector repercussions; reports in the media in one country The Homeopathy Research Institute website offers an
– spread across the world, often with distorted or in-depth resources area that provides accurate and reliable
Joining the incomplete information. information to those who want the facts about homeopa-
thy research. The widely used Frequently Asked Questions
In the evolving world of instant information, ‘fake news’
debate and increasing globalisation, access to accurate and
section gives clear, evidence-based answers to the most
commonly repeated criticisms of homeopathy.
reliable data is all the more important. Despite many
ill-informed attacks on our sector in the media and In 2017, this material was made available in Portuguese and
Homeopathy is the subject of Russian, adding to versions in English, French, German,
elsewhere, its stakeholders – scientists, doctors, homeo-
much public debate, often with paths, pharmacists, patients and users as well as industry Italian, Spanish, Swedish and Chinese. The expanded
global repercussions. – continue to engage actively in the debate, speaking out range of translations means that quality information is
in favour of this long-established therapy and working to now available to stakeholders, policy makers and decision
ensure that high quality information is available to those takers in the health field across the globe, helping ensure
who need it. informed debate about homeopathy and well-informed
decisions based on the latest information.
In 2017, a number of initiatives were taken by other
stakeholders in the field, with the support of ECHAMP,
to strengthen the availability of quality information; New information sources for
ECHAMP believes that balanced, accurate information is European patients
essential to ensure proper integration of homeopathy into In 2017, the European Federation of Homeopathic Patients’
health care and in support of the hundreds of millions of Association (EFHPA) launched a revitalised website, a
people worldwide who choose homeopathy to support jumping-off point for patient information in Europe, with
their health. information in Dutch, English, French, German, Italian
and Spanish.
The website is a hub for a dynamic and multilingual social
media presence for patients in Europe. EFHPA’s active
Facebook and Twitter accounts share positive information
about homeopathy around Europe in multiple languages.

10 echamp annual report 2017

Membership Assembly 2017 Member services
Inside ECHAMP ECHAMP’s annual Membership Assembly (pictured overleaf) ECHAMP offers its members the opportunity to make
was held in Berlin 24–25 April, bringing together members their voice heard through active participation in policy
from around the EU for two days of meetings, annual development at EU level, ensuring a strong voice for
We thank our members for their formalities, networking and a delightful dinner cruise common interests of the sector. In 2017, members came
hard work and contribution. on the river Spree. The meeting was chaired by Mathias together to campaign against the new legislation on the
Hevert, Board member of ECHAMP and Managing import and export of mercury (see page 6), so as to secure
Director of Hevert Arzneimittel. We were pleased to the future import and export of mercury and its com-
welcome many CEOs from our member companies to a pounds used as starting material for homeopathic and
dedicated workshop to discuss the future of our sector. anthroposophic medicinal products.
The 2018 annual Membership Assembly will be held Experts from ECHAMP member organisations also
in Marseille, 16–17 April. The chair of the Membership worked systematically and thoroughly to review and
Assembly will be Christopher Wise, of French member give feedback on technical consultation documents from
company, Sevene Pharma. HMPWG. We are grateful to all who took part in these
initiatives and thank them for their hard work and
Members have access to a wealth of sector and industry
information, specialised expertise and resources and the
chance to network and share good practice with other
industry and sector representatives.
In addition to its website, ECHAMP’s —
information services include ‘News ECHAMP
from ECHAMP’, which provides up-
dates on developments affecting the Members
sector (35 news items in 2017), early have access
warnings on potential crises, monthly
briefings for members and, three times
to a wealth
a year, a round-up of relevant stories of sector
in the news. and industry
expertise and

ECHAMP members discuss

the future of our sector.

echamp annual report 2017 11

ECHAMP membership 2017 Picture right
ECHAMP members meet
In April, ECHAMP Members voted unanimously in favour at the Membership Assembly
in Berlin in April 2017
of welcoming a new French full member, Laboratoires
Gilbert, a family owned company founded in 1904 that
offers natural self-medication solutions for the whole
family; its new range, ‘LG Homéo’, includes homeopathic
medicines for the treatment of everyday ailments. This
brings the total number of full members of ECHAMP
to 45, from 19 different EU Member States.





Ireland Kingdom Poland

Belgium Czech
Full Member of ECHAMP

France Austria Hungary

Associated Partner of ECHAMP Switzerland

Italy Bulgaria



12 echamp annual report2017

ECHAMP, the European Coalition on Homeopathic &
Anthroposophic Medicinal Products, is the European
association of companies that work closely together
to ensure that its members can meet the demand
from users and prescribers across the EU for these
products. It advocates in favour of an appropriate
regulatory environment for these products in the EU.

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