Law news community jun-august 04 eng
June - August 2004
EUROPEAN COMMUNITY
LAW NEWS
DIRECTIVE ON TAKEOVER BIDS
offeree company; (ii) sufficient time and
European Parliament and Council Directive
sufficient information provided to the
2004/25/EC of 21 April 2004 on takeover bids
addressees of the bid; (iii) the board of the
offeree company acting in the interests of
Directive 2004/25/EC of 21 April 2004 on
the company as a whole; (iv) preventing
takeover bids (13th directive) was adopted
creation of false markets (i.e. where the rise
in the context of the Financial Services
or fall in the prices of the securities becomes
Action Plan adopted in 1999, stipulating
artificial and the normal functioning of the
policy objectives and specific measures for
market is distorted); (v) ensuring that an
improving the single market in financial
offeror can fulfil in full any cash or other
services. After refusal by the European
consideration offered; (vi) minimum possible
Parliament of the previous proposal for a
hindering of an offeree company's activities
directive on takeover bids in July 2001, the
present Directive takes into account the
remarks of members of the European
For the regulation of bids, Member States
Parliament, as well as the recommendations
may lay down additional conditions and
made by the Group of High-Level Company
provisions more stringent than those of the
Law Experts set up by the Commission.
Directive. Member States are to designate
the authority or authorities competent to
Pursuant to the Directive, the "takeover bid"
supervise bids, and inform the Commission
or "bid" means a "public offer (other than by
of those designations. The Directive further
the offeree company itself) made to the
lays down rules for deciding the applicable
holders of the securities of a company to
law and the competent supervisory
acquire all or some of those securities,
whether mandatory or voluntary, which
follows or has as its objective the acquisition
For the purposes of protection of minority
of control of the offeree company in
shareholders, the Directive provides for a
accordance with national law" Article 2 (1) (a).
mandatory bid, which must be executed by
a person holding securities of a company
The Directive applies to "takeover bids for
which give him a specified percentage of
the securities of companies governed by the
voting rights, giving him control of that
laws of Member States, where all or some of
company. Such a bid must be addressed at
those securities are admitted to trading on a
the earliest opportunity to all the holders of
regulated market (within the meaning of
those securities for all their holdings at the
Directive 93/22/EEC of 10 May 1993 on
equitable price, i.e. the highest price paid for
investment services in the securities field) in
the same securities by the offeror, or by
one or more Member States" Article 1 (1).
persons acting in concert with him, over
The Directive does not apply to takeover
a period, to be determined by the Member
bids for securities issued by collective
States, of not less than six months and not
investment companies, or to takeover bids
more than twelve before the bid. The
for securities issued by the Member States'
obligation to launch a bid does not apply
central banks.
where control has been acquired following
Hurbanovo nám. 5
a voluntary bid to all the holders of securities
811 03 Bratislava, Slovak Republic
The Directive sets forth the following general
for all their holdings.
tel.: (421-2) 54 41 44 41
principles for the conduct of takeover bids,
fax: (421-2) 54 43 45 98 e-mail:
[email protected]
with which the legal regulation of the
The Directive further stipulates the main
Member States must comply: (i) equal
rules concerning the provision of information
treatment for all holders of securities of the
on takeover bids to the supervisory
branch: Avenue d'Auderghem 36 B-1040, Brussels, Belgium Tel.: +32 (0) 2 230 32 15 fax: +32 (0) 2 230 33 47 e-mail:
[email protected]
June - August 2004
EUROPEAN COMMUNITY LAW NEWS
authorities, to the public, as well as to
medicine authorization and the UK licensing
employees representatives of the offeree
company or its employees.
We informed you in the last ECLN issue
The Directive also contains the requirement
(ECLN 01 - 05/2004) of the amended EC
that the board of the offeree company must
rules on medicinal products, including
obtain the prior authorisation of its
Directive 2004/27/EC of the European
shareholders before taking any defensive
Parliament and of the Council amending
action, or the requirement to freeze
Directive 2001/83/EC on the Community
members' extraordinary rights (such as
Code relating to medicinal products for
multiple voting rights, appointment rights
and restrictions on the transfer of securities)during the bid, however, it leaves it up to
New provisions inserted in Directive
Member States whether or not to apply
2001/83, specifically its Articles 6 and 10,
them. In case a Member State decides not
extend the possibility of abridged
to apply these provisions generally, it must
applications for generic medicines. In
give to the companies themselves particular, Directive 2001/83 now providesa possibility to decide whether they want to
that "when a medicinal product has been
apply these rules.
granted an initial marketing authorization[…] any additional strengths, pharma-
The Directive lays down a "squeeze-out
ceutical forms, administration routes,
right" enabling a majority shareholder to
presentations, as well as any variations and
require the remaining minority shareholders
extensions shall also be granted an
to sell their securities, which is combined
authorization […] or be included in the initial
with a "sell-out right" enabling minority
marketing authorization. All these marketing
shareholders to require the majority
authorizations shall be considered as
shareholder to buy their securities following
belonging to the same global marketing
a takeover bid.
authorization, in particular for the purpose ofthe application of Article 10 (1) [abridged
More detailed rules governing the conduct
application for generic medicines]" (Article 6
of bids, especially the lapsing of bids, the
(1) subparagraph 2).
revision of bids, competing bids, thedisclosure of the results of bids, the
In other words, this new provision effectively
irrevocability of bids and the conditions
limits the data protection period applicable
permitted must be laid down by the
to the contents of the file of a particular
medicine and its later developments to tenyears from the date of first marketing in the
The Directive entered into force on 20 May 2004 and
Community. As a result, new versions of the
Member States are required to transpose the Directive
medicine, based on the initial application file,
no later than 20 May 2006.
are subject to the data protection period
Official Journal of the European Union, 2004, L 142
initially granted. The data protection periodinitially granted is extended "to a maximum
of eleven years only if, during the first eightyears of those ten years, the marketing
PHARMACEUTICALS - ABRIDGED
authorization holder obtains an authorization
REGISTRATION OF GENERIC
for one or more therapeutic indications
which during the scientific evaluation prior to
Opinion of Advocate General Jacobs in Approved
their authorization, are held to bring a
Prescription Services Ltd (C-36/03) of 8 July 2004
significant client benefit in comparison toexisting therapies" (Article 10 (1)
The Advocate General Jacobs rendered an
subparagraph 4).
opinion on 8 July 2004, in the case C-36/03)between the applicant for a generic
In the present case before the High Court of
June - August 2004
EUROPEAN COMMUNITY LAW NEWS
England and Wales the generic medicine is
Sidel in 2001, Tetra Laval had failed to fully
fluoxetine, also the name of the active
disclose relevant research & development
ingredient, in a liquid pharmaceutical form
data and intellectual property rights by not
(product C). The abridged application made
providing information about the Tetra Fast
in 1999, refers to Product B, the medicine
technology. This failure happened both in
Prozac, containing the same active
the Form CO and in response to a letter in
ingredient, also manufactured in liquid form.
which the Commission asked for
Although the marketing authorization of
information, which should have led to the
product B was granted in 1992 (less than
disclosure of the Tetra Fast technology. The
the ten year data protection period with
existence of the Tetra Fast technology was
regard to the application of product C) the
revealed only after the adoption of the
application of product B was made in
Commission's decision of October 2001.
reference to Product A, also Prozac but intablet form which was authorized in 1988
The Commission imposed a fine of EUR
(i.e. more than ten years data protection
90,000 for the infringements. It should be
noted, however, that the fines in questionwere imposed under the old merger
The question asked by the High Court of
regulation. The new Merger Regulation (see
England and Wales to the Court of Justice is
ECLN 12/2003 - 1/2004) in force since 1
whether the relevant Community rules
May 2004, companies can be fined up to
should be interpreted as allowing an
1% of their aggregate turnover for supplying
application for product C to refer to product
incorrect or misleading information.
B authorized for less than ten years, andtake into account product A, reference
medicine of product B and authorized formore than ten years.
REDUCTION OF FINE FOR CARTEL OF
STEEL PRODUCERS
The conclusions of Advocate General
Judgments of the Court of First Instance in Steel Tube
Jacobs which, essentially, build on the
Producers (Cases T-44/00, T-48/00, T-50/00 andJointed Cases T-67/00, T-68/00, T-71/00 and T-78/00)
provision decisions of the Court in cases of
Generics (C-368/96) and Novartis (C-106/01), and recommends that the generic
In December 1999, the Commission
marketing application of product C should
adopted a decision concluding that eight
be accepted as submitted, are followed by
companies (four European and four
the Court of Justice, the result may be
Japanese) producing certain types of
equivalent to an early application of the new
seamless carbon-steel pipes and tubes
provisions of Directive 2001/83.
used in the oil industry had participated inthe period of 1990 - 1995 in a cartel
agreement. The agreement, which wasconcluded at meetings known as the
COMPETITION - FINES FOR
"Europe-Japan Club", consisted of a
division of the markets so that each of the
INFORMATION IN MERGER CONTROL
companies undertook not to sell the pipes
and tubes in question on the domesticmarket of any other company that was a
In June 2004, the European Commission
party to that agreement. Given the general
decided, for the fifth time in the history only,
prohibition of cartel agreements set forth in
to impose a fine to a company for providing
Article 81 of the EC Treaty, the Commission
incorrect or misleading information in
imposed on all eight producers fines of a
merger proceedings. The company fined is
total amount of EUR 99 millions.
the carton packaging company Tetra LavalB.V.
Seven out of eight convicted producerssubsequently filed an action for annulment
The Commission discovered that during its
of the Commission's decision before the
examination of Tetra Laval's acquisition of
Court of First Instance (the "Court"). The
June - August 2004
EUROPEAN COMMUNITY LAW NEWS
Court rejected all arguments of the steel
The Japanese companies also contested
producers except for arguments relating to
the date on which the infringement imputed
the duration of the infringement concerned
on them had ended. The Court held that it
and, consequently, on the size of the fines
had not been established, in the case of the
Japanese undertakings, that theinfringement had continued beyond 1st July
Given that between 1977 and 1990, certain
1994 and, therefore, considered it
voluntary agreements between the
necessary to reduce the duration of the
European Community and Japan on
infringement by an additional six months.
restraint of imports have been in force, theCommission concluded that although it
Consequently, the Court partially annulled
could have set the start-date of the
the Commission's decision and slightly
infringement as 1977, the infringement
reduced respective fines to a total amount
started, for the purpose of the proceedings,
of EUR 86 million.
only in 1990. The Court noted that itsexamination must not relate to the legality or
appropriateness of that concession of theCommission, but only to the question
FINANCING OF PROMOTIONAL
whether the Commission correctly applied it
ACTIVITIES AS STATE AID
in this case.
Judgment of the Court of Justice in Pearle and Others(C-345/02) of 15 July 2004
The Japanese producers, however, claimedthat the voluntary agreements between the
Dutch law provides for the establishment of
EC and Japan have lasted till the end of
industry associations and entrusts to them a
1991 (not 1990). They, however, were not
certain scope of internal autonomy. The
able to produce any direct evidence to that
case concerns a Dutch chamber of traders
end and nor was the Commission able to
active on the market of optic products
demonstrate the opposite, although it was
which, by virtue of its internal bye-laws,
the Commission who represented the EC in
imposed specific charges on its members.
negotiations with Japan on the voluntary
These charges were used solely to finance
agreements. The Court recalled that
advertising activity designed to promote
although, in general, an applicant (the
optical products for the benefit of the
Japanese producers) cannot transfer the
Chamber' members.
burden of proof to the defendant, theconcept of burden of proof couldn't be
The dispute arose between the chamber
applied for the benefit of the Commission in
and three of its members, private
this case. Consequently, the Court
corporations active in the optic industry,
considered, by way of exception, that it was
which contested the levy of the charge by
incumbent on the Commission to produce
the chamber. The plaintiffs argued that the
evidence of when such voluntary
charge shall be qualified as state aid within
agreements had ceased to exist. The Court
the meaning of applicable Community law.
finally concluded, also on the basis of
Since the alleged state aid had not been
certain indirect evidence produced by the
notified to the Commission, as is normally
Japanese producers, that for the purposes
required under Community law, the plaintiff
of these proceedings, and having regard to
argued that the decision of the chamber to
the burden of proof falling upon the
levy the charge was invalid and that the
Commission regarding the existence of an
charges already collected were subject to
infringement, the voluntary restraint
agreements concluded between theCommission and the Japanese authorities
The Court has ruled in favour of the
remained in force during 1990. In view of
Chamber. It noted that state aid is defined
that finding of fact the Court decided that
as any support granted directly or indirectly
the duration of the infringement was
from public funds, which may be attributed
reduced by one year.
to the activity of public authorities.
June - August 2004
EUROPEAN COMMUNITY LAW NEWS
That definition does not seem, in the Court's
system. The plaintiff submitted that certain
opinion, to cover the charge collected by
of the Community safety requirements were
the chamber. The revenues so acquired
not complied with in one waste water
were used only in the interest of the
treatment plant.
members, which benefited from thepromotional activities. Thus, the benefits
The Commission wrote to the Italian
enjoyed by the members were not related to
authorities in August 2000 requesting
any allocation or transfer of public funds
information regarding the matters raised in
since any advantages which the members
the complaint, in order to examine the
might have obtained were financed by
situation in greater detail. The Italian
means of the charge collected from them.
authorities did not reply to that request, norto a subsequent one of March 2001.
The Court also set aside, as irrelevant to thiscase, the argument that both the activities
Considering that the silence of the Italian
and authority of the Chamber, including the
authorities constituted an absence of
right to impose charges, were based on the
genuine cooperation on their part, for the
provisions of Dutch public laws on
purposes of Article 10 EC, the Commission
entrepreneurship. The Court also pointed
instituted a procedure under Article 226 EC.
out that the decision of the chamber to
After putting the Italian Republic on notice to
impose the charge was taken at the request
submit its observations, the Commission
of some of its members. As such, the
issued a reasoned opinion in July 2002 in
charge was not a part of the general policy
which it called on the Italian authorities to
of the Dutch public authorities and could not
adopt the measures necessary for
have been attributed to them.
compliance within two months of itsnotification. As the Italian authorities failed to
OBLIGATION OF LOYALTY
respond, the Commission brought the
Judgement of the Court of Justice in Commission of
present action against the Italian Republic
the European Communities v Italian Republic (C-82-03)
before the Court in February 2003.
The Italian Republic claimed that the lack of
By this judgement, the Court of Justice
information on the name and location of the
confirmed its case law concerning Article 10
plant created an objective difficulty for the
of EC Treaty, in particular its judgement in
Italian authorities to identify the supervisory
Case 192/84, Commission v Greece, and
bodies responsible to conduct targeted
Case C-478/01, Commission
inspections and provide the requested
v Luxembourg. Article 10 EC requires
information. The Court decided that the
Member States to take all appropriate
place, which was the subject of the
measures to ensure fulfilment of their
complaint, was sufficiently clearly identified
obligations arising out of the EC Treaty or
in the letters of the Commission sent before
resulting from action taken by Community
the pre-litigation procedure, and, therefore,
institutions. According to the Court, Article
the Italian Republic had failed to fulfil its
10 EC creates an obligation for Member
obligations under Article 10 EC.
States to cooperate in good faith with theenquiries of the Commission pursuant to
Article 226 EC, and provide it with all theinformation requested for that purpose.
JUDICIAL COOPERATION - EUROPEAN
ENFORCEMENT ORDER
In 2000, the Commission received Regulation no. 805/2004 of the European Parliament
a complaint regarding the application of
and of the Council of 21 April 2004 creating a European
Council Directive 89/655/EEC of 30
Enforcement Order for uncontested claims
November 1989 concerning the minimumsafety and health requirements for the use of
The Regulation represents an important
work equipment within the Italian legal
step for the proper functioning of the internal
June - August 2004
EUROPEAN COMMUNITY LAW NEWS
market in the field of judicial cooperation in
A judgement that has been certified as a
civil matters as it provides for free circulation
European Enforcement Order by the court
of judgements, court settlements and
of origin is recognised and enforced in the
authentic instruments for uncontested
other Member States without the need for a
claims throughout the Member States
declaration of enforceability and without any
(except Denmark).
possibility of opposing its recognition. Itmust be treated as if it had been delivered in
At present, a judgement issued in one
the Member State in which enforcement is
Member State can be enforced in another
Member State after it has been recognisedas an enforceable title by the Member State
The Regulation comes into force on 1 January 2005
where the enforcement of such judgement
and shall apply from 21 October 2005.
has been sought. Such procedure is
Official Journal of the European Union, 2004, L 143, p 15
governed by the Council Regulation44/2001 on jurisdiction and the recognition
and enforcement of judgements in civil andcommercial matters. This intermediate
COMPENSATION TO CRIME VICTIMS
procedure, however, still involves delays and
Council Directive No. 2004/80/EC relating to
expenses for the person seeking the
compensation to crime victims
Directive 2004/80/EC aims to abolish
Under the Regulation, such requirement of
obstacles to the free movement of services
a prior declaration of enforceability is
by drawing up minimum standards for the
abolished in respect of judgements, court
protection of crime victims. Such protection
settlements and authentic instruments (such
is considered corollary of that freedom of
as enforceable notarial records) provided
movement and Member States are obliged
they concern uncontested claims in civil and
to implement the Directive by 1 January
commercial matters and that certain specific
conditions stipulated in the Regulation aremet.
The Directive sets up a system ofcooperation in order to facilitate the access
An uncontested claim is a claim to which the
to compensation for victims of violent
debtor has expressly agreed or to which the
intentional crimes in cross-border situations.
debtor has never objected in the course of
It will enable access to compensation in
the court proceedings or a claim where the
cases where the crime was committed in a
debtor has not appeared at a court hearing
Member state different from the state of
that claim. As the Regulation seeks to
victim's residence. Each Member State is
promote the fundamental rights, more
thus obliged to ensure that, where a violent
particularly the right to a fair trial, certain
intentional crime has been committed in a
minimum procedural standards must be
Member State different from the Member
met in the (court) proceedings in the
State where the victim has habitual
Member States of origin. Consequently, a
residence, the victim shall have the right to
certificate is issued only provided the
submit the application for compensation in
documents instituting the proceedings have
the Member State where the crime took
been properly served on the debtor, that the
debtor has been properly informed aboutthe claim in question and about procedural
The compensation system under the
steps necessary to contest the claim.
Directive will operate on the basis of thecompensation schemes existing of the
A certificate of a European Enforcement
Order is issued by the court of origin uponapplication.
For the purpose of the Directive, eachMember State shall appoint a central
June - August 2004
EUROPEAN COMMUNITY LAW NEWS
contact point, which will provide applicants
whenever the transmission would contain
with necessary information and assistance.
indirect advertising of alcohol beverages.
Furthermore, the Member States mustestablish standard forms, which will be used
However, the Court pointed out that
for applications for compensation. The
restrictions to the free movement of services
compensation will be paid by the authority
introduced by the Member States may be
of the Member State on the territory of
justified on the grounds of public health
which the crime was committed.
considerations. The Court found Frenchprovisions proportionate to that aim. The
Official Journal of the European Union, 2004, L 261, p 15
measures at issue were designed to limit thenumber of events available on television
where the public might have viewedadvertisements of alcohol and thus might
RESTRICTIONS ON ALCOHOL
have been encouraged to consume alcohol.
ADVERTISING IN BROADCASTS OF
SPORTS EVENTS
According to the Court, in line with well
Judgment of the Court of Justice in Commission
established case law, the fact that it is lawful
v France (C-262/02) of 13 July 2004
to show advertisements of tobaccoproducts during television broadcasts of
French laws prohibit advertising of alcohol
sports events, is not relevant. Member
on television under the pain of prosecution
States are free to define objectives of their
and administrative sanctions. Furthermore,
public health policy and correspondingly
under established practice, French
choose implementing measures. Therefore,
television broadcasters might have been
total prohibition in France of television
precluded from broadcasting sports events
alcohol advertisements may be deemed
where alcohol was indirectly advertised on
proportionate, regardless of measures
banners, billboards, T-shirts of the teams
applied by other Member States.
etc. That applied, in particular, to bilateralsports events addressed directly to the
French public. In such cases, Frenchbroadcasters were required to refrain from
LABELING OF FOODSTUFFS
broadcasting should the organisers provide
Judgment of the Court of Justice in the case Douwe
advertising facilities concerning alcohol
Egberts (C-239/02) of 15 July 2004
The Court of Justice has issued a decision
The Commission enforced proceedings
regarding claims which may be inserted on
against France under Article 226 EC
the labeling of foodstuffs. A brand of ground
claiming infringement of the free movement
coffee marketed in Belgium and carrying
of services, particularly of advertising and
slimming and weight control claims was
broadcasting services. The Court has,
challenged in court by a competitor arguing,
however, rejected charges against France.
among others, a breach of severalprovisions of national and Community law
The Court admitted that an infringement of
regarding the labeling and the advertising of
free movement of services was involved.
The Court noted that, for instance, theequipment owners were required to reject
The interpretation of relevant Community
advertisements of alcohol products
rules and the compatibility of applicable
whenever a sports event was to be
national rules with Community law were
broadcasted in France. Furthermore, French
referred to the European Court of Justice.
broadcasters were precluded frombroadcasting those games where alcohol
While Directive 1999/4/EC harmonizes the
advertisements were displayed. Organisers
definition of coffee extract and chicory
were in turn prevented from selling
extracts, the main relevant Community
broadcasting rights to French operators
provisions are contained in Directive
June - August 2004
EUROPEAN COMMUNITY LAW NEWS
2000/13/EC on the approximation of the
FREE MOVEMENT OF GOODS -
laws of the Member States relating to the
labeling, presentation and advertisement of
Judgment of the Court of Justice in case Nicolas
foodstuffs (the Directive). The Directive
Schreiber (C-443/02) of 15 July 2004
harmonizes national rules and prohibitslabeling which, (i) "attributes to any foodstuff
The decision of the Court makes
the property of preventing, treating or curing
a combined application of Community rules
a human disease, or refer to such properties",
harmonizing national laws (Directive
and (ii) "contains misleading references to
98/8/EC concerning the placing of biocidal
health". These provisions apply to the labeling
products on the market) and of basic
and to the advertising of foodstuffs.
provisions of the European CommunityTreaty (EC) on the free movement of goods,
In addition, the Directive requires Member
Article 28 EC and 30 EC.
States to allow the marketing of foodstuffswhich are in compliance with the Directive,
The case was referred to the Court of
except for national measures regarding
Justice after criminal proceedings were
labeling (not advertising) justified by the
started against Mr. Schreiber following the
protection of public health (Article 18 (2) of
placing on the market, in Italy, of blocks of
the Directive). National measures must
red cedar wood having natural anti-moth
nevertheless be compatible with the general
properties. The product was legally
principles of Community law.
marketed in Germany where no priormarketing authorization was required. In
In the present case, the court decided that
contrast, applicable Italian rules require prior
national rules (here a Belgian Royal Decree)
authorization of such products.
which absolutely prohibit references to"slimming" (as opposed to the prohibition of
Under Directive 98/8, biocidal products are
misleading references only) do not comply
defined as "active substances and
with the requirement of proportionality (a
preparations containing one or more active
general principle of Community law) with
substances, put up in the form in which they
regard to both Article 18 (2) of the Directive
are supplied to the user, intended to destroy,
(as to labeling) or to Article 28 EC (as to
deter, render harmless, prevent the action
advertising) prohibiting restrictions to the
of, or otherwise exert a controlling effect on
trade of goods between Member States.
any harmful organism by chemical orbiological means". While products falling
In particular, the Court of Justice considers
under the definition of biocidal product are
such national provision as not proportionate
subject to authorization, the Directive
as it does not allow the marketing of
creates two further categories, respectively,
products carrying slimming claims which are
low-risk biocidal products subject only to
substantiated, and for which, therefore, the
registration and inclusion in annex IA to the
slimming claim has an informative function.
Directive and basic substances which may
Moreover, the aim of protection public
be marketed if listed in annex IB to the
health would still be satisfied through a
procedure of verification of claims made.
As Directive 98/8 is not fully implemented,
Finally, the Court recalls the long standing
notably its annexes are still being
principle, recently applied in the case Darbo
established, the Court considers that the
(C-465/98) of 20 April 2000, that it is up to
effective harmonization provided by the
the national court to decide on the existence
Directive is currently limited to the definition
of a fraudulent statement, "taking into
of biocidal product and that such definition
account the presumed expectations of an
covers blocks of red cedar wood having
average consumer who is reasonably well
natural anti-moth properties.
informed and reasonably observant andcircumspect".
Since other rules contained in Directive 98/8are not yet effective, the Court considered
that the review of national rules, beyond the
June - August 2004
EUROPEAN COMMUNITY LAW NEWS
definition of biocidal product, was subject toArticles 28 EC and 30 EC, regarding the freemovement of goods. Applying itsestablished case law, the Court concludesthat the requirement for authorizationcontained in the Italian legislation is anobstacle to trade between Member States(prohibited by Article 28 EC), but goes on tosay that such requirement is (a) justifiedgiven the qualification of the product as abiocidal product, potentially harmful tohuman health, and (b) proportionate to thelegitimate objective of protecting publichealth (under Article 30 EC). In thisconnection, the Court specifically recallsthat the fact that one Member State has lessstrict rules (here Germany) than another(here Italy), does not mean that the rules ofthe second State are disproportionate withregard to Community law.
The Court decision recalls that untilharmonizing Community rules are fullyimplemented, or the scope of Communityrules in force, Member States may stillmaintain national rules provided such rulesare legitimate under Treaty rules (hereArticle 30EC), (for example the protection ofpublic health) and proportionate. The Courtdoes however refer to ongoing activities forthe implementation of Directive 98/8, inparticular Commission Regulation2032/2003 amending Regulation1896/2000, to determine its position.
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EUROPEAN COMMUNITY LAW NEWS
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Advokátska kancelária âechová Rakovsk˘ZdruÏenie advokátov: JUDr. Boris Bohunsk˘ (evidenãné ãíslo v zozname advokátov vedenom Slovenskou advokátskou komorou: 1070/318 039 38), JUDr. Katarína âechová (0339/317 831 63) poverená vedením úãtovníctva zdruÏenia pod Iâ DPHSK1020333083, JUDr. Denisa Kubínyiová (1116/318 039 20), Mgr. TomበMaretta(1601/318 172 11), Mgr. Jana Moravãíková (3866/103 515 07 21), Mgr. ZuzanaPetrá‰ová (2157/318 155 96)
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Source: http://www.cechova.sk/en/Documents/ECLN/AJ/2004/ecln%20june-august%202004.pdf
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GDP and Integrity of The Supply Chain Presented by: Karen S Ginsbury B.Pharm, MSc, MRPharmS IFF, October 2010 What are the Risks What are the Risks in GDP? • For a formal assessment need to use one of the tools in ICH Q9 / Annex 20: – HACCP– FMEA– Ishikawa (Fishbone) diagram + one of the • Will take you to a lot of the points already Every Picture Tells a Story