CELEX: 51990PC0072(01)
Language: en
Date: 1990-03-22
Title: PROPOSAL FOR A COUNCIL DIRECTIVE WIDENING THE SCOPE OF DIRECTIVES 65/65/EEC AND 75/319/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES ON MEDICINAL PRODUCTS AND LAYING DOWN ADDITIONAL PROVISIONS ON HOMEOPATHIC MEDICINAL PRODUCTS

COMMISSION OF THE EUROPEAN COMMUNITIES
                                                           C0MC90) 72 f i n a l - SYN 251/252
                                                           B r u s s e l s , 22 March 1990
                                        Proposal f o r a
^SffiE                                                                                     SYN 251
                                      COUNCIL DIRECTIVE
         widening t h e scope of D i r e c t i v e s 65/65/EEC and 75/319/EEC on the
            approximation of the laws of the Member States on m e d i c i n a l
                 products and l a y i n g down a d d i t i o n a l p r o v i s i o n s on
                            homeopathic m e d i c i n a l products
                                        Proposal f o r a
                                                                                          SYN 252
                                      COUNCIL DIRECTIVE
        widening the scope of Directive 81/851/EEC on the approximation of
          the laws of the Member States on veterinary medicinal products
               and laying down additional provisions on homeopathic
                             veterinary medicinal products
                             (presented by the Commission)
 ---pagebreak---                                         - 2 -
              EXPLANATORY MEMORANDUM AND REPORT TO THE COUNCIL
1
 •  Qenerai remarks
    1.   When the Council adopted Directive 87/22/EECi, and
         specifically Article 5 thereof, It instructed the Commission to
         present it with "proposals for Regulations to harmonize, along
         the lines of Directive 75/319/EEC, the conditions for
         authorizing the manufacture and placing on the market of the
         proprietary medicinal products excluded by Article 34 of
         Directive 73/319/EEC2 and of the veterinary medicinal
         products referred to In Article 2(2) of Directive
         81/851/EEC5".
    2.   Three of the four kinds of medicines for human use which were
         provisionally excluded in 1975 have recently been incorporated
          into Community pharmaceutical legislation, namely:
          Immunological medicinal products by Directive 89/342/EEC*,
         radio-pharmaceuticals by Directive 89/343/EEC5 and medicinal
         products derived from human blood by Directive 89/381/EEC6.
          In the veterinary field, a proposal for a Directive on
          Immunological medicinal products was transmitted to the Council
          in January 19897. It has proved more difficult to harmonize
          legislation on homeopathic medicinal products because of the
         conflicting conceptions of medicine involved.
(1) OJ N° L 15, 17.1.1987, p.38.
(2) OJ N p L 147, 9.6.1975, p.13.
(3) OJ N° L 317, 6.11.1981, p.1.
(4) OJ N° L 142, 25.5.1989, p.14.
(5) OJ N p L 142, 25.5.1989, p.16.
(6) OJ N° L 181, 26.6.1989, p.44.
(7) OJ N° C 61, 10.3.1989, p.20.
 ---pagebreak---                                    - i -
3. While homeopathic medicine has traditionally been recognized in
   some Member States, it has merely been tolerated in others or even
    ignored by orthodox medicine altogether. Nonetheless, homeopathy
   has been practised in Europe for more than two centuries and has
   become Increasingly popular with the public in the last decade or
   so with the rise In "natural" therapies and alternative medicine.
4.  It Is not for the Commission to take sides for or against a
   particular style of medical practice. The aim should be rather, In
   the light of legislative experience In some of the Member States,
   to provide European consumers with safeguards about the quality and
   safety of the homeopathic medicines currently available In all
   Community countries. Proof of therapeutic efficacy cannot be
   obtained by generally accepted scientific methods or, at the least,
   is highly contentious.
5. Whether recognized or simply tolerated, homeopathic remedies
   represent a small but not insignificant share of the
   pharmaceuticals market, of the order of half a billion
   (500 000 000) ECU. Trade between Member States Is impeded by the
   differences In regulation and practice at national level. The
   proposals the Commission is now presenting to the Council, on
   homeopathic medicinal products for human and for veterinary use,
   are intended to further the completion of the Internal market in
   the pharmaceuticals sector as provided for In the 1985 White Paper
   programme.
 ---pagebreak---                                      - 4 -
 !
  '' ALTERNATIVE REMEDIES IN EUROPE
6.   In 1987 the Commission asked the Belgian Consumers' Association to
     carry out a study on the market for alternative medicine among
     European consumers. This study, written by G. Sermus, covers seven
     Community countries (Belgium, Denmark, Germany, France, Italy,
     Netherlands, United Kingdom) as well as Finland and Switzerland. It
     shows that a considerable proportion of the population (from 18% to
     75% depending on country) makes use of alternative therapies.
     Homeopathy Is the principal method among them, well ahead of
    acupuncture and manipulations such as chiropractic, osteopathy and
    various types of massage. Then come herbal remedies, followed by
    what one might call "paranormal" methods, Including mystical and
     religious approaches. Finally the author lists what he classifies
    as fringe methods (In Europe) such as iridology, anthroposophy,
     "biomedlclne", aroma therapy, cell therapy and hypnotherapy. The
    author notes that it is generally aduits between the ages of 40 and
    60 with a high level of education who make most use of alternative
    medIcI ne.
7.  These diverse therapies have little In common except being almost
    uniformly rejected by science as lacking a rational basis. Whereas
    conventional or allopathic medicine has made considerable progress
    through advances In biology, pharmacology and surgical techniques,
    the various forms of alternative medicine generally adopt an
    empirical approach backed by what are often obscure explanations.
    But conventional medicine Itself does not meet all the expectations
    of patients with certain chronic or supposedly "incurable"
    diseases. Furthermore, patients are often put off by the impersonal
    and highly technological nature of modern medicine. The alternative
    medicines, on the other hand, tend to be holistic in the sense that
    they look at the person as a whole and encourage the patient to
    participate in the healing process. Although alternative medicine
    can be sincere in approach and rest on established traditions, It
    must be admitted that a degree of opportunism has developed to
    exploit recent fashions, even to the extent of combining methods
    that are Incompatible.
 ---pagebreak---                                       - 5 -
8.  Homeopathic remedies represent by far the most Important type of
    alternative medicines used in Europe. For our present purposes,
    plant-based medicinal products will be considered as belonging to
    the allopathic or conventional tradition; medicinal herbs are in
    fact the origin of many modern medicines, either by extraction or
   by synthesis, although the action of the plant as a whole may be
   poorly understood. While allopathy treats a condition by tackling
    the causes or, at second-best, the symptoms, homeopathy is based on
    the principle of similarity - like cures like - and extreme
   dilutions. The theory was developed by Samuel Hahnemann (1755-1843)
   and consists of trying to cure the patient by administering very
   small doses of a substance which, in a healthy individual, would
   produce similar symptoms to those observed In the patient. This
   theory has evolved into various opposing schools: complex Ists,
   pluralIsts ("materialists") and unieIsts ("dynamists").
   Anthroposophy (following Rudolf Steiner) and "biomedlcine"
   (following Dr Schuss 1er), which are more widespread in Germany than
    In the rest of the Community, make frequent use of homeopathic
   remedies while being based on other Ideas.
9. When the Community's pharmaceuticals directives were being
   transposed Into German law In the "Arznelmlttelgesetz 1976", a
   wide-ranging debate took place about the position of alternative
   remedies. The quality of homeopathic and anthroposophlc medicines
   Is standardized in a separate official pharmacopoeia
   (HomeopathIsches Arzneibuch - HAB); such medicinal products are
   evaluated by special committees of the Federal Health Office
   (Bundesgesundheltsamt - BGA). France also has a well-established
   homeopathic tradition, with special authorization procedures and
   the Inclusion of monographs on homeopathic preparations and 'mother
   tinctures' or stocks In the French Pharmacopoeia (editions V I M and
   X ) . Homeopathic medicinal products are also mentioned, albeit in
   much less detail, in the pharmaceutical legislation of Belgium,
   Denmark, the Netherlands, the United Kingdom and Ireland. These
   countries, as well as Italy and Portugal, are waiting to see what
   action the Community will take before reviewing their own
   legislatIon.
 ---pagebreak---                                  - 6 -
III. CONSULTATIONS AT COMMUNITY LEVEL
10.   In the period since 1987, the Commission has put three
     successive preliminary drafts of a Directive on homeopathic
     medicinal products to the Pharmaceuticals Committee, which is
     composed of representatives of the Member States. The reaction
     to these drafts varied widely according to the different
     national positions, from official recognition to outright
     rejection. Since homeopathic medicines are available on all the
     national markets, there have been suggestions that they be
     classified as articles for household consumption rather than as
     medicines. However, this does not seem consistent either with
     the Community definition of medicinal products or with the
     instructions given by the Council. While some convergence of
     views seems possible In the case of traditional homeopathic
     medicines, the same cannot be said of anthroposophical
     products, nor of aspects felt to carry too much risk
     (preparations for injection, for example) or considered hardly
     compatible with the basic principles of homoeopathy
     (encouragement of self-medlcation).
11.  The preliminary draft Directive on homeopathic medicinal
     products for human use was distributed widely through several
     European organizations representing professionals in the field:
     the pharmaceuticals Industry (EFPIA), homeopathic and
     anthroposophic laboratories, the Association of EEC pharmacists
     and mutual pharmacies, and homoeopaths and anthroposophical
     practitioners. The overall reaction was positive, since the
     draft text introduced greater legal security while eliminating
     various sharp practices which damage the reputation of serious
     practitioners. At the request of the Commission, the Consumers'
     Consultative Committee Issued an opinion on 16 February 1989;
     this was favourable, and was accompanied by complete and
     detailed reference documentation. In addition to this, an
     international workshop on homeopathic medicines was held in
     Berlin on 2 and 3 February 1989 at the Invitation of the
     Federal Health Office; 11 health ministries of European
     countries were represented, as well as the Commission. Most of
     the participants met again In Strasbourg on 17 and 18 May at
     the invitation of the Secretary of the European Pharmacopoeia.
 ---pagebreak---                                      - 7 -
12. Several preliminary drafts of a Directive on medicinal products for
    veterinary use have been submitted to the Committee for Veterinary
    Medicinal Products. Despite the great differences between
    countries, most members of the Committee underlined the need to
     improve standards of quality and safety for this category of
    medicines, which are being used more and more. The competant
    authorities would also like to eliminate a number of abuses in the
    field, in particular the sale of medicines described as homeopathic
    for collectively treating livestock as part of specific medications
    for which a therapeutic effect has not been shown.
IV. THE QUALITY OF HOMEOPATHIC MEDICINES
13. Homeopathic medicinal products are defined primarily by the way
    they are made up, as described in the European Pharmacopoeia if It
    Is extended to include homeopathy or, If not, in national
    pharmacopoeias (currently those of France and Germany). This
    "objective" method of definition, which Is the one adopted in the
    German legislation, has the advantage of not taking sides In the
    argument over the philosophy or rational basis of homeopathy or
    other traditions using the same products, such as is often the case
    for anthroposophy. Homeopathic medicines should be clearly
    Identifiable as such for the general public, by means of a special
    legend on the label, so that there can be no confusion between
    these, more controversial, homeopathic products and orthodox
    medicines. The general approach of Community pharmaceutical
    legislation Is followed in that the proposals cover only medicines
    which are widely distributed, I.e. prepared industrially and thus a
    major potential risk for the public, in particular by being sold In
    Intra-Communlty trade. This would not affect In any way the right
    to prescribe or prepare other alternative therapies in Individual
    cases according to magistral or officinal formulae, within the
    bounds of current national legislation.
 ---pagebreak---                                      - 8 -
14. The wide distribution of industrially prepared homeopathic
    medicines means that the first priority must be to harmonize the
    manufacture and monitoring of them. Apart from having to comply
    with the European Pharmacopoeia or, If not covered by It, the
    existing official pharmacopoeias, homeopathic medicines will become
    subject to all the Community rules safeguarding the quality of
    medicinal products manufactured in and Imported/exported to or from
    the Community. A consequence Is that the authorization to
    manufacture, export or Import such products will be conditional on
    possession of suitable premises and equipment. All raw materials
    and each batch manufactured will have to be monitored by a
    qualified person, who will Issue a properly registered certificate
    of conformity. The rules of good manufacturing practice (GMP) will
    become mandatory, which is particularly Important In the case of
    highly diluted products. Establishments will also become subject to
    regular monitoring by pharmaceuticals Inspectors. The competent
    authorities In the Member States will be required to exchange
     inspection reports and other data relevant to safeguarding the
    quality and safety of homeopathic medicines.
V.  PLACEMENT OF HOMEOPATHIC MEDICINES ON THE MARKET
15. Harmonizing the terms on which homeopathic medicines are to receive
    market authorization poses more complicated problems. Some Member
    States, while accepting that it is useful to ensure the quality of
    homeopathic products, do not want to give them official status and
    yet are prepared to admit products legally sold in other Member
    States, within certain constraints. On the other hand, where a
    Member State wishes to regulate the marketing of homeopathic
    medicines It will have a choice between two different regimes.
 ---pagebreak---                                       - 9-
 16. The first of these, full harmonization, consists of a simplified
      registration procedure applicable to medicinal products which,
     without therapeutic claims being made, are put up in pharmaceutical
     forms and at dilutions that carry no risk. Such medicines, sold
     under their common name and bearing a fully harmonized labelling,
     will usually be prescribed by a practitioner qualified according to
     the specific features of the case under treatment. Medicines of
     this type will be considered to belong to the homeopathic tradition
     and their therapeutic effect Is to be assessed in terms of that
     tradition.   Since some of the Information would be repetitive, it
     will be possible to combine dossiers to cover a series of like
     preparations.
17. The other, and more rigorous, regime cannot be entirely harmonized
     at this Juncture. For homeopathic medicines other than those
     qualifying for the simplified registration procedure, proof of
     therapeutic effect balanced against potential risks will have to be
     provided. Member States will apply either the ordinary rules on
     market authorization, especially criteria of efficacy and safety,
     or special rules for homeopathic preparations. In this second case,
     these special rules will have to be notified to the Commission with
     a view to later harmonization.
VI. CONCLUSIONS
18. By 1993, with the entry Into effect of the Directives, homeopathic
     medicines sold in the Community will all have to meet the same high
     quality standards. First-time applications for registration or
     authorization will be examined under the terms of the Directives.
     Experience with implementation will lead to a greater convergence
     of practice as between Member States despite the present wide
     differences.
 ---pagebreak---                                     - 10 -
    In accordance with Articles 8a and 8c of the Treaty establishing
    the European Economic Community, the Commission calls on the Member
    States to take the necessary steps to comply with the proposals
    presented here by 1 January 1993.
19. The Commission has given due consideration to the requirements of
    Article 8c of the Treaty and has concluded that no special
    provisions are needed In this case.
    The Commission has also looked at the matter of the high level of
    protection for health, safety, the environment and consumers
    required by the third paragraph of Article 100a. This review was
    conducted after consulting concerned parties and after analysing
    the Inherent risks in this area, given current technical capacity
    within European Industry. The proposals take full account of these
    factors, in the light of the underlying aims of the Treaty.
 ---pagebreak---                                         - 11 -
                                  Proposal for a
                                COUNCIL DIRECTIVE
     widening the scope of Directives 65/65/EEC and 75/319/EEC on the
        approximation of the laws of the Member States on medicinal
              products and laying down additional provisions on
                        homeopathic medicinal products
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having    regard   to  the   Treaty     establishing   the  European   Economic
Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission*1),
 In cooperation with the European Par I lament*2>,
Having regard to the opinion of the Economic and Social Committee*3*,
Whereas differences currently existing between the provisions laid down
by law, regulation or administrative action          in the Member States may
hinder trade in homeopathic medicinal products within the Community;
Whereas    the  essential   aim   of   any  rules  governing   the  production,
distribution and use of medicinal products must be to safeguard public
health;
Whereas    the  provisions   of    Council   Directive  65/65/EEC*4^   and  the
Second    Directive    75/319/EEC*5*,      as   last   amended   by   Directive
             6
89/341/EEC* *, are not      always appropriate      for homeopathic   medicinal
products;
(1)
(2)
(3)
(4) OJ No 22, 9.2.1965, p. 369/65.
(5) OJ No L 147, 9.6.1975, p. 13.
(6) OJ No L 142, 25.5.1989, p. 11.
 ---pagebreak---                                             - 12 -
Whereas homeopathic medicine is officially recognized in certain Member
States   but    Is    only   tolerated    in  other    Member   States;   whereas,
therefore, It Is appropriate to recognize certain national homeopathic
traditions without Imposing them throughout the Community;
Whereas   even     if   homeopathic    remedies    are   not  always    officially
recognized, they are nevertheless prescribed and used               in ail   Member
States;
Whereas It Is desirable in the first Instance to provide users of these
remedies with a clear        indication of their homeopathic character          and
with sufficient guarantees of their quality and safety;
Whereas   the   rules     relating   to   the  manufacture,     the   control   and
inspection of homeopathic medicinal           products must    be harmonized     to
permit the circulation throughout the Community of preparations which
are safe and of good quality;
Whereas,   having     regard   to the particular      characteristics of      these
medicinal products, such as their very low content of active principles
and the difficulty of applying to them the conventional                statistical
methods relating to clinical         trials, it is appropriate to provide a
simplified    registration      system   for   those    traditional    homeopathic
medicinal   products which are placed on the market without               specific
therapeutic Indications in a preparation which does not present a risk
for the patient;
Whereas, however, the usual rules governing the authorization to market
medicinal products should be applied to a homeopathic medicinal product
marketed with therapeutic indications or in a form which may present
risks which must be balanced against the desired therapeutic effect;
whereas those Member States which have a homeopathic tradition should
 ---pagebreak---                                      13 -
be able to apply particular rules for the evaluation of tests and
trials Intended to establish the safety and efficacy of these medicinal
products provided that they notify them to the Commission,
HAS ADOPTED THIS DIRECTIVE:
 ---pagebreak---                                    - 14 -
                              Chapter I : Scope
Article 1
For  the purposes of this Directive       "homeopathic medicinal      product"
shall   mean  any   medicinal   product  prepared    In accordance     with   a
homeopathic    manufacturing    procedure    described    by    the   European
Phamacopoeia, or In the absence thereof, by the official pharmacopoeia
of a Member State.
Homeopathic   preparations   are produced    from products, substances or
compositions called homeopathic stocks by successive dilutions.
Article 2
1.  The   provisions   of  this Directive    shall   apply   to   industrially
    prepared   homeopathic   medicinal  products    for  human    use  to   the
    exclusion of homeopathic medicinal products prepared In accordance
    with a magistral or an officinal formula as defined In Article 1 of
    Directive 65/65/EEC.
2.  The   medicinal   products   referred   to   In  paragraph     1  must   be
    identified by the inclusion on their labels in clearly legible form
    of the words "homeopathic medicinal product".
 ---pagebreak---                                      - 15 -
             Chapter II: Manufacture, Control and Inspection
Article 3
The provisions of Chapter IV of Directive 75/319/EEC shall apply to the
manufacture,   control,   Import  and   export   of  homeopathic   medicinal
products.
Article 4
The measures of supervision and the sanctions provided for In Chapter V
of Directive 75/319/EEC shall apply to homeopathic medicinal products
together with Articles 31 and 32 of the same Directive.
However, the proof of therapeutic effect mentioned in Article 28(1)(b)
of the same Directive shall not be required for homeopathic medicinal
products registered in accordance with Article 7 of this Directive.
Article 5
The Member States shall communicate to each other all the information
necessary to guarantee the quality and safety of homeopathic medicinal
products  manufactured   and   marketed   within   the  Community,   and  in
particular the Information mentioned in Articles 30 and 33 of Directive
75/319/EEC.
 ---pagebreak---                                   - 16 -
                   Chapter III: Placing on the market
Articfa 6
1.  Member  States shall   ensure that   homeopathic medicinal  products
    manufactured and marketed within the Community are registered or
    authorized In accordance with the provisions of Articles 7, 8 and
    9.  Each Member State shall take registrations and authorizations
    previously granted by another Member State Into due consideration.
2.  A  Member  State   may  refrain  from  establishing  any  system  of
    registration or authorization for homeopathic medicinal products.
    A Member State applying this provision shall Inform the Commission
    thereof.  The Member State concerned shall allow the use in its
    territory   of   homeopathic   medicinal   products  registered   or
    authorized by other Member States In accordance with Articles 7, 8
    and 9.
 ---pagebreak---                                        - 17 -
     Article 7
 1.  Homeopathic medicinal     products shall    be subject     to a simplified
     registration    procedure   If  they   satisfy    all   of   the   following
     conditions:
              they are administered orally or externally;
             they    are   marketed    without    any    specific     therapeutic
              indication, whether on the labelling of the product or in
             any accompanying product Information;
             there is a sufficient degree of dilution to guarantee the
             safety of the preparation;       in particular, the preparation
             shall contain less than one part per million of any active
             principle which is subject to the requirement of a medical
             prescription.
2.   In  addition   to   the  clear   mention    of   the  words    "homeopathic
    medicinal product", the labelling and packaging of the homeopathic
    medicinal products referred to In paragraph 1 shall consist of the
    following Information and no other information:
             the scientific name of the stock followed by the degree of
             dilution,    using    the   symbols    used     in   the    official
             pharmacopoeia of the Community,
             name and address of the person responsible for marketing,
             and of the manufacturer,
             method of administration,
             expiry date, in plain language,
             special storage precautions, if any,
             manufacturer's batch number,
             registration number.
3.  The criteria and rules of procedure provided for in Articles 5 to
    12   of    Directive   65/65/EEC    shall    apply    to    the   simplified
    registration procedure for homeopathic medicinal products, with the
    exception of the proof of therapeutic effect.
 ---pagebreak---                                    - 18 -
Article 8
An application for a simplified registration submitted by the person
responsible for marketing may cover a series of preparations derived
from the same homeopathic stock.     The following documents shall   be
included with the application In order to demonstrate, in particular,
the pharmaceutical quality and the batch to batch consistency of the
products concerned:
    scientific name of the homeopathic stock, together with a mention
    of the various routes of administration, pharmaceutical forms and
    dilutions to be registered;
    dossier describing how the stock is obtained and controlled, and
    justifying  Its homeopathic nature, on the basis of an adequate
    homeopathic bibliography;
    manufacturing and control file for each pharmaceutical form and a
    description of the method of dilution;
    manufacturing authorization for the preparations concerned;
    copies of any registrations or authorizations obtained for the same
    preparations in other Member States-,
    one or more specimens or mock-ups of the sales presentation of the
    preparations to be registered.
 ---pagebreak---                                       - 19 -
Article 9
1.  Homeopathic medicinal    products other   than those  referred  to  In
    Article 7 shall be authorized and labelled in accordance with the
    provisions   of   Articles 5   to 21   of   Directive  65/65/EEC   and
    Articles 1 to 7 of Directive 75/319/EEC, including the provisions
    concerning proof of therapeutic effect.
2.  A Member State may lay down specific rules for the pharmacological
    and   toxIcolog lea I tests   and  clinical   trials  of   homeopathic
    medicinal products other than those referred to In Article 7.       In
    this case, before the date referred to in Article 10 (1) the Member
    State concerned shall notify the Commission of the specific rules
    in force.
 ---pagebreak---                                    - 20 -
                      Chapter IV: Final Provisions
Article 10
1.  Member States shall take the    measures necessary to comply with
    this   Directive  by  31 December   1992. They   shall   inform the
    Commission thereof forthwith.
    The provisions adopted pursuant to the first subparagraph shall
    make express reference to this Directive.
2.  Applications for registration or for marketing authorization for
    products covered by this Directive lodged after the date set out in
    paragraph 1 shall comply with the provisions of this Directive.
Article 11
This Directive is addressed to the Member States
Done at Brussels,                                For the Council
                                                   The President
 ---pagebreak---                                       - 21 -
                                  Proposal for a
                                COUNCIL DIRECTIVE
     widening the scope of Directive 81/851/EEC on the approximation
        of the laws of the Member States on veterinary medicinal
      products and laying down additional provisions on homeopathic
                        veterinary medicinal products
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having   regard   to   the   Treaty    establishing   the  European   Economic
Community, and In particular Article 100a thereof,
Having regard to the proposal from the Commission*1*,
In cooperation with the European Parliament*2*,
Having regard to the opinion of the Economic and Social Committee*3*,
Whereas differences between the provisions laid down by law, regulation
or  administrative    action   in the Member    States may   hinder  trade   in
homeopathic veterinary medicinal products within the Community;
Whereas   the  essential   aim    of  any  rules  governing   the  production,
distribution   and   use  of   veterinary   medicinal   products  must   be  to
safeguard human and animal health;
Whereas   the provisions     of   Council  Directive   81/851/EEC*4*   are  not
always appropriate for homeopathic veterinary medicinal products;
(1)
(2)
(3)
(4) OJ No L 317, 6.11.1981, p. 1.
 ---pagebreak---                                            - 22 -
Whereas homeopathic medicine is officially recognized In certain Member
States   but    Is    only   tolerated    In   other   Member   States;   whereas,
therefore, it Is appropriate to recognize certain national homeopathic
traditions without imposing them throughout the Community;
Whereas   even     If   homeopathic    remedies    are   not  always    officially
recognized, they are nevertheless prescribed and used               In all Member
States;
Whereas It Is desirable in the first instance to provide users of these
remedies with a clear        Indication of their homeopathic character and
with sufficient guarantees of their quality and safety;
Whereas   the    rules    relating   to   the   manufacture,    the   control   and
Inspection    of    homeopathic    veterinary     medicinal   products    must   be
harmonized    to   permit    the  circulation     throughout   the   Community   of
preparations which are safe and of good quality;
Whereas,   having     regard   to the particular      characteristics of      these
medicinal products, such as their very low content of active principles
and the difficulty of applying to them the conventional                statistical
methods relating to clinical trials, It Is appropriate to provide a
simplified    registration      system   for    those   traditional    homeopathic
veterinary medicinal products which are placed on the market without
specific   therapeutic      Indications     in a   preparation   which   does   not
present a risk for the animal or the consumer of animal products;
 ---pagebreak---                                    - 23
Whereas, however, the usual rules governing the authorization to market
veterinary  medicinal  products  should  be  applied  to  a  homeopathic
veterinary medicinal product marketed with therapeutic indications or
in a form which may present risks which must be balanced against the
desired therapeutic effect; whereas those Member States which have a
homeopathic tradition should be able to apply particular rules for the
evaluation of tests and trials Intended to establish the safety and
efficacy of  these veterinary medicinal    products provided  that  they
notify them to the Commission,
HAS ADOPTED THIS DIRECTIVE:
 ---pagebreak---                                       - 24 -
                                Chapter I : Scope
Article 1
For the purposes of this Directive "homeopathic veterinary medicinal
product"   shall  mean   any    veterinary    medicinal    product  prepared   in
accordance with a homeopathic manufacturing procedure described by the
European Pharmacopoeia, or        In the absence thereof, by the official
pharmacopoeia of a Member State.
Homeopathic   preparations    are produced      from products, substances or
compositions called homeopathic stocks by successive dilutions.
Article 2
1.  The   provisions   of   this    Directive    shall   apply   to   homeopathic
    veterinary medicinal products to the exclusion of products prepared
    by a pharmacist or a veterinarian in accordance with a magistral or
    an officinal formula and Intended for administration to a single
    animal or a small number of animals.
2.  The   medicinal   products     referred    to   in   paragraph   1   must  be
     identified by the inclusion on their labels in clearly legible form
    of the words "homeopathic medicinal product, for animal treatment
    only".
3.  This   Directive   shall     not   apply   to   immunological     homeopathic
    veterinary medicinal products which shall be authorized by Member
    States   in accordance     with   the provisions of       Council   Directive
    90/.../EEC   [extending    the scope of Directive 81/851/EEC on           the
    approximation   of    the    laws  of   the   Member   States   relating   to
    veterinary medicinal products and laying down additional provisions
    for immunological veterinary medicinal products]* 5 *.
(5) OJ No L
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             Chapter II: Manufacture, Control and Inspection
Article 3
The provisions of Chapter V of Directive 81/851/EEC shall apply to the
manufacture, control,    import  and  export   of  homeopathic   veterinary
medicinal products.
Article 4
The  measures   of  supervision   and  the   sanctions   provided   for   in
Chapter VI  of   Directive   81/851/EEC   shall   apply    to   homeopathic
veterinary medicinal products.
However, the proof of therapeutic effect mentioned in Article 37(1)(b)
of the same Directive shall not be required for homeopathic veterinary
medicinal  products registered    in accordance with Article 7 of       this
Directive.
Article 5
The Member States shall communicate to each other all the information
necessary to guarantee the quality and safety of homeopathic veterinary
medicinal products manufactured and marketed within the Community, and
in particular   the  information mentioned    in Articles 39 and     42 of
Directive 81/851/EEC.
 ---pagebreak---                                      - 26 -
                    Chapter M l : Placing on the market
Article 6
1.  Member States shall ensure that homeopathic veterinary medicinal
    products   manufactured   and   marketed   within  the  Community  are
    registered   or  authorized   In accordance with    the provisions of
    Articles 7, 8 and 9.     Each Member State shall take registrations
    and authorizations previously granted by another Member State Into
    due consideration.
2.  A  Member   State  may   refrain   from  establishing  any  system  of
    registration or authorization for homeopathic veterinary medicinal
    products.   A Member State applying this provision shall inform the
    Commission thereof.    The Member State shall allow the use in its
    territory of homeopathic veterinary medicinal products registered
    or authorized by other Member States in accordance with Articles 7,
    8 and 9.
 ---pagebreak---                                            27 -
   Article 7
1. Homeopathic veterinary medicinal         products shall be subject            to a
   simplified    registration    procedure     If   they   satisfy     all    of   the
   fo11owIng cond11 i ons:
            they are administered orally or externally;
            they    are    marketed    without     any    specific      therapeutic
            indication,     whether   on   the   labelling    of    the   medicinal
           product or in any accompanying product information;
           there is a sufficient degree of dilution to guarantee the
           safety of the preparation, and in the case of homeopathic
           veterinary medicinal       products    Intended for administration
           to   food   producing    animals, to guarantee         the absence of
           harmful residues In foodstuffs produced from these animals;
            in particular, the preparation shall contain less than one
           part per million of any active principle which                is subject
           to the requirement of a veterinary prescription.
2. In  addition    to   the   clear   mention    of    the  words     "homeopathic
   medicinal product, for animal treatment only", the                labelling and
   packaging of the homeopathic veterinary medicinal products referred
   to in paragraph 1 shall consist of the following information and no
   other information:
           the scientific name of the stock followed by the degree of
           dilution,      using   the    symbols     used     in    the     official
           pharmacopoeia of the Community,
           name and address of the person responsible for marketing,
           and of the manufacturer,
           method of administration,
           expiry date, In plain language,
           special storage precautions, if any,
           manufacturer's batch number,
           registration number,
           In the case of products intended for administration to food
           producing     animals,    a   statement     that    there     is   a   nil
           withdrawal period.
 ---pagebreak---                                        28 -
3.   The criteria and rules of procedure provided for in Articles 8 to
      15  of  Directive  81/851/EEC   shall  apply   to   the  simplified
     registration   procedure   for  homeopathic   veterinary   medicinal
     products, with the exception of the proof of therapeutic effect.
Article 8
An application for a simplified registration submitted by the person
responsible for marketing may cover a series of preparations derived
from    the same homeopathic stock.   The following   documents shall  be
 included with the application In order to demonstrate, in particular,
the pharmaceutical quality and the batch to batch consistency of the
products concerned:
     scientific name of the homeopathic stock, together with a mention
     of the various routes of administration, pharmaceutical forms and
     dilutions to be registered;
     dossier describing how the stock is obtained and controlled, and
     justifying  Its homeopathic nature, on the basis of an adequate
     homeopathic bibliography;
     manufacturing and control file for each pharmaceutical form and a
     description of the method of dilution;
     manufacturing authorization for the preparations concerned;
     copies of any registrations or authorizations obtained for the same
     preparations In other Member States;
-    one or more specimens or mock-ups of the sales presentation of the
     preparations to be registered.
 ---pagebreak---                                    - 29 -
Article 9
Homeopathic veterinary medicinal products other than those referred to
in Article 7 shall be authorized and labelled in accordance with the
provisions of Articles 5 to 15 of Directive 81/851/EEC, including the
provisions  concerning  proof  of  therapeutic effect,  and  shall  be
labelled  In accordance with the provisions of Articles 43 to 50 of
Directive 81/851/EEC.                v.-
 ---pagebreak---                                      - 30 -
                      Chapter IV: Final Provisions
Article 10
1.  Member States shall take the measures necessary to comply with this
    Directive by 31 December 1992. They shall     inform the Commission
    thereof forthwith.
    The provisions adopted pursuant to the first subparagraph shall
    make express reference to this Directive.
2.  Applications for registration or for marketing authorization for
    products covered by this Directive lodged after the date set out In
    paragraph 1 shall comply with the provisions of this Directive.
Article 11
This Directive Is addressed to the Member States,
Done at Brussels,                                        For the Council
                                                          The President
 ---pagebreak---                                    - 31 -
                  IMPACT ON COMPETITIVENESS AND EMPLOYMENT
1. What is the main reason for introducing the measure?
   White Paper on completing the internal market; improvement of
   protection of public health; instructions from the Council to Include
   in Community legislation all industrially produced medicinal products
2. Features of the businesses concerned
   The market for   homeopathic medicines is relatively restricted (2% of
   the market for pharmaceuticals). Industrial preparation of homeopathic
   medicines Is carried out by about 15 Community companies which are
   disadvantaged by present legislation and the lack of legal certainty
   for their activities in some Member States where homeopathy    is not
   recognized. Small manufacturing or dilution runs produced by local
   homeopathic , dispensing pharmacies are not affected by the proposals.
   According to the information available to the Commission, the
    industrial-scale firms are located particularly in certain areas:
   France, Germany, United Kingdom; however, their products are already
   being sold throughout the Community.
3. What direct obligations does this measure impose on businesses?
   The measures introduced all seem necessary to protect the consumer and
   should therefore already be standard practice for a bona fide producer;
   in particular:
 ---pagebreak---                                      - 32 -
   - good pharmaceutical manufacturing practice,
   - a qualified person to check and certify each production batch,
   - submission of documentation, especially a bibliography, to guarantee
     the quality and safety of the homeopathic medicines so produced.
   Firms must also agree to try to standardize the quality of raw
   materials and production processes, as has already been achieved in
   some countries (Germany, France) but which still remain to be
   harmonized In the context of the European Pharmacopoeia (Council of
   Europe convention).
4
 - What obligations are local authorities likely to Impose on businesses?
   National-level inspection of premises and manufacturing conditions,
   where this Is not already instituted by the national authorities.
5. Do any special measures apply In respect of SMEs?
   No, since products manufactured by local pharmacies on a small scale
   (magistral and officinal preparations) are not covered by the proposed
   measures.
6. What Is the likely effect on:
     (a) business competitiveness?
         A greater degree of harmonization in the production of
         homeopathic  medicines and the authorization of them could
         improve the competitiveness of both manufacturers geared to
         Intra-Communlty trade and producers with an interest In exporting
         outside the Community.
     (b) employment?
         No significant effect Is foreseen.
 ---pagebreak---                                  - 33 -
Have both sides of Industry been consulted?
Apart from the European federations representing manufacturers of
homeopathic  medicinal products, there has been consultation of
associations representing  homeopathic pharmacists and practitioners
The result has been general agreement on the principles behind the
measures proposed.
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                                                               COM(90) 72 final
                                                      DOCUMENTS
E N
                                                                            03 05
                                 Catalogue number : CB-CO-90-096-EN-C
                                                             ISBN 92-77-57911-0
Office for Officia] Publications of the European Communities
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