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Administrative cooperation in the field of taxation

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Administrative cooperation in the field of taxation

Outline of the Community (European Union) legislation about Administrative cooperation in the field of taxation

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Taxation

Administrative cooperation in the field of taxation

Document or Iniciative

Council Directive 2011/16/EU of 15 February 2011 on administrative cooperation in the field of taxation and repealing Directive 77/799/EEC.

Summary

This directive repeals Directive 77/799/EEC and establishes new rules and procedures for the cooperation between European Union (EU) countries with a view to exchanging information that is relevant to the administration and enforcement of national laws in the field of taxation. It applies to all taxes except the following:

  • value added tax (VAT) and customs duties, or excise duties covered by other EU legislation on administrative cooperation between EU countries;
  • compulsory social security contributions payable to the EU country;
  • fees, such as for certificates and other documents issued by public authorities;
  • dues of a contractual nature, such as consideration for public utilities.

In accordance with this directive, on 17 June 2011 the Commission published a list of the EU countries’ competent national authorities in the Official Journal. The competent authority must designate a single central liaison office which is responsible for contacts with other EU countries in the field of administrative cooperation and may be responsible for contacts with the Commission. The competent authority may also designate liaison departments and competent officials with competences assigned according to national legislation or policy. Where a liaison department or a competent official receives a request for cooperation requiring action which is outside their area of competence, they must immediately send such a request to their country’s central liaison office and inform the requesting authority thereof.

EXCHANGE OF INFORMATION

Exchange of information on request

The requested authority must, at the request of the requesting authority, communicate any relevant information that it has in its possession or that it obtains from administrative enquiries. In order to obtain the requested information or to conduct the administrative enquiry requested, the requested authority must follow the same procedures as it would when acting on its own initiative or at the request of another authority in its own EU country. EU countries may not refuse to supply information solely because this information is held by a bank or other type of financial institution.

The requested authority must confirm receipt of the request within seven working days and must then provide the information as quickly as possible, and no later than six months after receipt of the request. If, however, the requested authority already possesses the information, it must be provided within two months of that date.

Mandatory automatic exchange of information

Each competent national authority must send to the competent authority of any other EU country, by automatic exchange, available information concerning taxable periods as from 1 January 2014 relating to residents in that other EU country on the following categories of income and capital:

  • income from employment;
  • director’s fees;
  • life insurance products not covered by other EU legal instruments on exchange of information and other such measures;
  • pensions;
  • ownership of and income from immovable property.

Spontaneous exchange of information

Each competent national authority must communicate information to the competent authority of any other EU country in the following situations:

  • the competent authority of one EU country has reason to suppose that there may be a loss of tax in the other EU country;
  • a person liable to tax obtains a reduction in, or an exemption from, tax in one EU country which would give rise to an increase in tax or to liability to tax in the other EU country;
  • business dealings between two persons liable to tax in different EU countries are conducted through one or more countries in such a way that a saving in tax may result in either or both of the EU countries;
  • the competent authority of one EU country has grounds for supposing that a saving of tax may result from artificial transfers of profits within groups of enterprises;
  • information forwarded to one EU country by another EU country’s competent authority has enabled information to be obtained which may be relevant in assessing liability to tax in the latter EU country.

Feedback

If requested, the competent authority which has received information has to send feedback to the sending country as soon as possible and no later than three months after the outcome of the use of the requested information is known.

OTHER FORMS OF ADMINISTRATIVE COOPERATION

Other forms of administrative cooperation include:

  • by agreement between the requesting authority and the requested authority, officials authorised by the requesting authority may be present in administrative offices and may participate in administrative enquiries in the requested country;
  • simultaneous controls of persons of common or complementary interest between two or more EU countries, with a view to exchanging the information obtained;
  • administrative notification;
  • sharing of best practices and experience to improve cooperation.

Any information communicated between EU countries in accordance with this directive is covered by the obligation of official secrecy and benefits from the protection extended to similar information under the national law of the EU country which received it. This information may be used in the following instances:

  • for the assessment and enforcement of other taxes and duties covered by Directive 2010/24/EU;
  • for the assessment and enforcement of compulsory social security contributions;
  • in judicial and administrative proceedings resulting from tax law infringements.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Directive 2011/16/EU

11.3.2011

1.1.2013

Article 8: 1.1.2015

OJ L 64, 11.3.2011

The placing of plant protection products on the market

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The placing of plant protection products on the market

Outline of the Community (European Union) legislation about The placing of plant protection products on the market

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Plant health checks

The placing of plant protection products on the market (until June 2011)

The European Union has harmonised the conditions and procedures for authorising plant protection products so as to protect human health and the environment. It has also drawn up a list of authorised substances and a phased programme for evaluating substances already on the market.

Document or Iniciative

Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market [See Amending Acts].

Summary

The Directive lays down uniform rules on the evaluation, authorisation, placing on the market and control within the European Union of plant protection products * and the active substances * they contain.

Only plant protection products whose active substances are listed in Annex I to the Directive and that do not pose a risk to human or animal health or the environment when the product is used under normal conditions are authorised.

The procedure for evaluating and authorising plant protection products must comply with the uniform principles laid down in Annex VI to the Directive. These include:

  • general principles: the evaluation of data in the light of current knowledge, taking account of the particular conditions prevailing in the zone in which the product is to be used, etc;
  • specific principles concerning, among other things, efficacy, the absence of unacceptable effects on plants, the impact on human and animal health and on non-target species, distribution in and impact on the environment, etc.

The Directive stipulates the requirements for the dossier to be submitted for the inclusion of an active substance in the list of authorised substances (Annex II) and the requirements for the dossier to be submitted for the authorisation of a plant protection product (Annex III). These requirements concern, among other things, the identification of the substance or product, the identity of the manufacturer and applicant for authorisation, tests and analyses carried out by official or officially-recognized testing facilities or organisations, etc. Information held by the applicant or manufacturer may be protected by a confidentiality clause where it constitutes an industrial or commercial secret.

Authorisation is granted by the Member State on whose territory the product is placed on the market for the first time. It is valid for ten years and may be renewed. It can be withdrawn if the requirements are no longer fulfilled and can be amended if the development of scientific and technical knowledge requires.

To ensure the free circulation of products, the Directive provides for mutual recognition of authorisations granted by the Member States, provided that the plant health, agricultural and environmental conditions are comparable in the regions concerned. It does, however, contain a protective clause permitting Member States temporarily to restrict or prohibit the circulation of a product on their territory if it poses a risk to human or animal health or to the environment.

Every quarter, the Member States inform the Commission and the other Member States of all plant protection products authorised or withdrawn. In addition, every year Member States draw up and send to the Commission and the other Member States a list of products authorised on their territory.

Arrangements for provisional authorisation allow Member States, pending the Community’s decision to include a new active substance in the positive list, to authorise the plant protection product concerned for a maximum of three years if the dossier submitted for inclusion of the active substance and the dossier for the authorisation of the plant protection product are in order and if it is established that the active substance and the product pose no risk.

As regards active substances currently on the market, the Directive provides for an evaluation programme for these substances over a period of 12 years from the entry into force of the Directive. This programme was extended until March 2009. Since the end of 2003, the European Food Safety Authority has been responsible for assessing risks, while the Commission is still responsible for taking decisions concerning risk management.

The Directive also harmonises the rules on the labelling and packaging of plant protection products and the information they must bear, among other things, the name and designation of the product, the name and address of the holder of the authorisation, the quantity of each active substance, the directions for use, the dose for each authorised use and particulars of possible phytotoxicity, etc.

Context

This Directive is repealed with effect from 14 June 2011 by Regulation (EC) No 1107/2009 on the placing on the market of plant protection products.

Key terms used in the act
  • Plant protection products: these are products consisting of, or containing, active substances, safeners or synergists, intended for one of the following uses:
    • protecting plants or plant products against all harmful organisms or preventing the action of such organisms, except if they are mainly designed for reasons of hygiene rather than protection of vegetables or vegetable products;
    • influencing the life processes of plants, other than as a nutrient (e.g. plant growth regulators);
    • preserving plant products, in so far as such substances or products are not subject to Community provisions on preservatives;
    • destroying undesirable plants, or parts thereof, with the exception of algae;
    • checking or preventing undesired growth of plants, except algae.
  • Active substances: substances or micro-organisms, including viruses, having general or specific action against harmful organisms or on plants, parts of plants or plant products.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Directive 91/414//EEC

26.7.1991 (notification)

26.7.1993

OJ L 230 of 19.8.1991
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 806/2003

5.6.2003

–

OJ L 122 of 16.5.2003

Regulation (EC) No 396/2005

5.4.2005

–

OJ L 70 of 16.3.2005

AMENDMENT OF ANNEXES

Annex I – Active substances authorised for use in plant protection products:

Directive 2000/80/EC (lambda-cyhalothrin) [Official Journal L 309 of 9.12.2000];
Directive 2001/21/EC (amitrole, diquat, pyridate and thiabendazole) [Official Journal L 69 of 10.3.2001];
Directive 2001/28/EC (fenhexamid) [Official Journal L 113 of 24.4.2001];
Directive 2001/47/EC (paecilomyces fumosoroseus) [Official Journal L 175 of 28.6.2001];
Directive 2001/49/EC (flupyrsulfuron-methyl) [Official Journal L 176 of 29.6.2001];
Directive 2001/87/EC (acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine and pyraflufen-ethyl) [Official Journal L 276 of 19.10.2001];
Directive 2001/99/EC (glyphosate and thifensulfuron-methyl) [Official Journal L 304 of 21.11.2001];
Directive 2001/103/EC (2,4-dichlorophenoxy acetic acid) [Official Journal L 313 of 30.11.2001];
Directive 2002/18/EC (isoproturon) [Official Journal L 55 of 26.2.2002];
Directive 2002/37/EC (ethofumesate) [Official Journal L 117 of 4.5.2002];
Directive 2002/48/EC (iprovalicarb, prosulfuron and sulfosulfuron) [Official Journal L 148 of 6.6.2002];
Directive 2002/64/EC (cinidon-ethyl, cyhalofop butyl, famoxadone, florasulam, metalaxyl-M and picolinafen) [Official Journal L 189 of 18.7.2002];
Directive 2002/81/EC (flumioxazine) [Official Journal L 276 of 12.10.2002];
Directive 2003/5/EC (deltamethrin) [Official Journal L 8 of 14.1.2003];
Directive 2003/23/EC (imazamox, oxasulfuron, ethoxysulfuron, foramsulfuron, oxadiargyl and cyazofamid) [Official Journal L 81 of 28.3.2003];
Directive 2003/31/EC (2,4-DB, beta-cyfluthrin, cyfluthrin, iprodione, linuron, maleic hydrazide and pendimethalin) [Official Journal L 101 of 23.4.2003];
Directive 2003/39/EC (propineb and propyzamide) [Official Journal L 124 of 20.5.2003];
Directive 2003/68/EC (trifloxystrobin, carfentrazone ethyl, mesotrione, fenamidone and isoxaflutole) [Official Journal L 177 of 16.7.2003];
Directive 2003/70/EC (mecoprop, mecoprop-P and propiconazole) [Official Journal L 184 of 23.7.2003];
Directive 2003/79/EC (coniothyrium minitans) [Official Journal L 205 of 14.8.2003];
Directive 2003/81/EC (molinate, thiram and ziram) [Official Journal L 224 of 6.9.2003];
Directive 2003/84/EC (flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate and silthiofam) [Official Journal L 247 of 30.9.2003];
Directive 2003/112/EC (paraquat) [Official Journal L 321 of 6.12.2003];
Directive 2003/119/EC (mesosulfuron, propoxycarbazone and zoxamide) [Official Journal L 325 of 12.12.2003];
Directive 2004/20/EC (chlorpropham) [Official Journal L 70 of 9.3.2004];
Directive 2004/30/EC (benzoic acid, flazasulfuron and pyraclostrobin) [Official Journal L 77 of 13.3.2004];
Directive 2004/58/EC (alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil and phenmedipham) [Official Journal L 120 of 24.4.2004];
Directive 2004/60/EC (quinoxyfen) [Official Journal L 120 of 24.4.2004];
Directive 2004/62/EC (mepanipyrim) [Official Journal L 125 of 28.4.2004];
Directive 2004/71/EC (Pseudomonas chlororaphis) [Official Journal L 127 of 29.4.2004];
Directive 2004/99/EC (acetamiprid and thiacloprid [Official Journal L 309 of 6.10.2004];
Directive 2005/2/EC (Ampelomyces quisqualis and Gliocladium catenulatum) [Official Journal L 20 of 22.1.2005];
Directive 2005/3/EC (imazosulfuron, laminarin, methoxyfenozide and s-metolachlor) [Official Journal L 20 of 22.1.2005];
Directive 2005/34/EC (etoxazole and tepraloxydim) [Official Journal L 125 of 18.5.2005];
Directive 2005/53/EC (chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl) [Official Journal L 241 of 17.9.2005];
Directive 2005/54/EC (tribenuron) [Official Journal L 244 of 20.9.2005];
Directive 2005/57/EC (MCPA and MCPB) [Official Journal L 246 of 22.9.2005];
Directive 2005/58/EC (bifenazate and milbemectin) [Official Journal L 246 of 22.9.2005];
Directive 2005/72/EC (chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb, and metiram) [Official Journal L 279 of 22.10.2005];
Directive 2006/5/EC (warfarin) [Official Journal L 12 of 18.1.2006];
Directive 2006/6/EC (tolylfluanid) [Official Journal L 12 of 18.1.2006];
Directive 2006/10/EC (forchlorfenuron and indoxacarb) [Official Journal L 25 of 28.1.2006];
Directive 2006/19/EC (1-methylcyclopropene) [Official Journal L 44 of 15.2.2006];
Directive 2006/39/EC (clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl and triticonazole) [Official Journal L 104 of 13.4.2006];
Directive 2006/41/EC (clothianidin and pethoxamid) [Official Journal L 187 of 8.7.2006];
Directive 2006/45/EC (propoxycarbazone) [Official Journal L 130 of 18.5.2006];
Directive 2006/64/EC (clopyralid, cyprodinil, fosetyl and trinexapac) [Official Journal L 206 of 27.7.2006];
Directive 2006/74/EC (dichlorprop-P, metconazole, pyrimethanil and triclopyr) [Official Journal L 235 of 30.8.2006];
Directive 2006/75/EC (dimoxystrobin) [Official Journal L 248 of 12.9.2006];
Directive 2006/85/EC (fenamiphos and ethephon) [Official Journal L 293 of 24.10.2006];
Directive 2006/131/EC (methamidophos) [Official Journal L 349 of 12.12.2006];
Directive 2006/132/EC (procymidone) [Official Journal L 349 of 12.12.2006];
Directive 2006/133/EC(flusilazole) [Official Journal L 349 of 12.12.2006];
Directive 2006/134/EC (fenarimol) [Official Journal L 349 of 12.12.2006];
Directive 2006/135/EC (carbendazim) [Official Journal L 349 of 12.12.2006];
Directive 2006/136/EC (dinocap) [Official Journal L 349 of 12.12.2006];
Directive 2007/5/EC (captan, folpet, formetanate and methiocarb) [Official Journal L 35 of 8.2.2007];
Directive 2007/6/EC (metrafenone, Bacillus subtilis , spinosad and thiamethoxam) [Official Journal L 43 of 15.2.2007];
Directive 2007/21/EC (azoxystrobin, imazalil, kresoxim-methyl, spiroxamin, azimsulfuron, prohexadion-calcium and fluroxypyr) [Official Journal L 97 of 12.4.2007];
Directive 2007/25/EC (dimethoate, dimethomorph, glufosinate, metribuzin, phosmet and propamocarb as active substances) [Official Journal L 106 of 24.4.2007];
Directive 2007/31/EC (fosthiazate) [Official Journal L 140 of 1.6.2007];
Directive 2007/50/EC (beflubutamid and Spodoptera exigua nuclear polyhedrosis virus) [Official Journal L 202 of 3.8.2007];
Directive 2007/52/EC (ethoprophos, pirimiphos-methyl and fipronil) [Official Journal L 214 of 17.8.2007];
Directive 2007/76/EC (fludioxonil, clomazone and prosulfocarb) [Official Journal L 337 of 21.12.2007];
Directive 2008/40/EC (amidosulfuron and nicosulfuron) [Official Journal L 87 of 29.3.2008];
Directive 2008/41/EC (chloridazon) [Official Journal L 89 of 1.4.2008];
Directive 2008/45/EC (metconazole) [Official Journal L 94 of 5.4.2008].
Directive 2008/66/EC (bifenox, diflufenican, fenoxaprop-P, fenpropidin and quinoclamine) [Official Journal L 171 of 1.1.2008].
Directive 2008/69/EC (clofentezine, dicamba, difenoconazole, diflubenzuron, imazaquin, lenacil, oxadiazon, picloram and pyriproxyfen) [Official Journal L 172 of 2.7.2008];
Directive 2008/70/EC (tritosulfuron) [Official Journal L 185 of 12.7.2008];
Directive 2008/91/EC (diuron) [Official Journal L 262 of 1.10.2008];
Directive 2008/107/EC (abamectin, epoxiconazole, fenpropimorph, fenpyroximate and tralkoxydim) [Official Journal L 316 of 26.11.2008];
Directive 2008/108/EC (flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat) [Official Journal L 317 of 27.11.2008];
Directive 2008/113/EC (several micro-organisms) [Official Journal L 330 of 9.12.2008];
Directive 2008/116/EC (aclonifen, imidacloprid and metazachlor) [Official Journal L 337 of 16.12.2008];
Directive 2008/125/EC (aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol) [Official Journal L 344 of 20.12.2008];
Directive 2008/127/EC (several active substances) [Official Journal L 344 of 20.12.2008];
Directive 2009/11/EC (bensulfuron, sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate and tebufenpyrad) [Official Journal L 48 of 19.2.2009];
Directive 2009/25/EC (pyraclostrobin) [Official Journal L 91 of 3.4.2009];
Directive 2009/37/EC (chlormequat, copper compounds, propaquizafop, quizalofop-P, teflubenzuron and zeta-cypermethrin) [Official Journal L 104 of 24.4.2009];
Directive 2009/51/EC (nicosulfuron) [Official Journal L 127 of 26.5.2009];
Directive 2009/70/EC (difenacoum, didecyldimethylammonium chloride and sulphur) [Official Journal L 164 of 26.6.2009];
Directive 2009/77/EC (chlorsulfuron, cyromazine, dimethachlor, etofenprox, lufenuron, penconazole, tri-allate and triflusulfuron) [Official Journal L 172 of 2.7.2009];
Directive 2009/82/EC (tetraconazole) [Official Journal L 196 of 28.7.2009];
Directive 2009/115/EC (methomyl) [Official Journal L 228 of 1.9.2009];
Directive 2009/116/EC (paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3) [Official Journal L 237 of 9.9.2009];
Directive 2009/117/EC (paraffin oil CAS No 8042-47-5 [Official Journal L 237 of 9.9.2009];
Directive 2009/152/EC (carbendazim) [Official Journal L 314 of 1.12.2009];
Directive 2009/153/EC (hydrolysed proteins) [Official Journal L 314 of 1.12.2009];
Directive 2009/154/EC (cyflufenamid) [Official Journal L 314 of 1.12.2009];
Directive 2009/155/EC (metazachlor) [Official Journal L 314 of 1.12.2009];
Directive 2009/160/EU (2-phenylphenol) [Official Journal L 338 of 19.12.2009].

Annex II – Requirements for the dossier to be submitted for the inclusion of an active substance in Annex I:

Directive 93/71/EEC [Official Journal L 221 of 31.8.1993];
Directive 94/37/EC [Official Journal L 194 of 29.7.1994];
Directive 94/79/EC [Official Journal L 354 of 31.12.1994];
Directive 95/35/EC [Official Journal L 172 of 22.7.1995];
Directive 95/36/EC [Official Journal L 172 of 22.7.1995];
Directive 96/12/EC [Official Journal L 65 of 15.3.1996];
Directive 96/46/EC [Official Journal L 214 of 23.8.1996];
Directive 96/68/EC [Official Journal L 277 of 30.10.1996];
Directive 2001/36/EC [Official Journal L 164 of 20.6.2001].

Annex III – Requirements for the dossier to be submitted for the authorisation of a plant protection product:

Directive 93/71/EEC [Official Journal L 221 of 31.8.1993];
Directive 94/37/EC [Official Journal L 194 of 29.7.1994];
Directive 94/79/EC [Official Journal L 354 of 31.12.1994];
Directive 95/35/EC [Official Journal L 172 of 22.7.1995];
Directive 95/36/EC [Official Journal L 172 of 22.7.1995];
Directive 96/12/EC [Official Journal L 65 of 15.3.1996];
Directive 96/46/EC [Official Journal L 214 of 23.8.1996];
Directive 96/68/EC [Official Journal L 277 of 30.10.1996];
Directive 2001/36/EC [Official Journal L 164 of 20.6.2001].

Annex IV – Risk phrases:

Directive 2006/104/EC [Official Journal L 363 of 20.12.2006].

Annex V – Safety phrases:

Directive 2006/104/EC [Official Journal L 363 of 20.12.2006].

Annex VI – Uniform principles for the evaluation and authorisation of plant protection products:

Directive 97/57/EC [Official Journal L 265 of 27.9.1997];
Directive 2005/25/EC [Official Journal L 90 of 8.4.2005].

Related Acts

Programme for the evaluation of existing substances

Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I [Official Journal L 15 of 18.1.2008].
This Regulation completes the programme of work on the gradual examination of active substances on the market and lays down rules for the submission and evaluation of applications for inclusion in Annex I to Directive 91/414/EEC. Two procedures are established: a regular procedure involving verification by the Member State of dossiers on the active substance concerned, and an accelerated procedure which can be followed in the case of non-inclusion of the active substance.

Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC [Official Journal L 379 of 24.12.2004].

Commission Regulation (EC) No 1112/2002 of 20 June 2002 laying down the detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC [Official Journal L 168 of 27.6.2002].

Commission Regulation (EC) No 451/2000 of 28 February 2000 laying down the detailed rules for the implementation of the second and third stages of the work programme referred to in Article 8(2) of Council Directive 91/414/EEC [Official Journal L 55 of 29.2.2000].

Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market [Official Journal L 366 of 15.12.1992].

This Regulation lays down detailed rules governing the relationship between industry, the Member States and the Commission for the implementation of the first phase of the programme, covering an initial series of 90 active substances.

Supplementary protection certificate for medicinal products

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Supplementary protection certificate for medicinal products

Outline of the Community (European Union) legislation about Supplementary protection certificate for medicinal products

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Pharmaceutical and cosmetic products

Supplementary protection certificate for medicinal products

Document or Iniciative

Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) (Text with EEA relevance).

Summary

The purpose of the supplementary protection certificate for medicinal products is to remedy the disparities and shortcomings in national patenting systems for pharmaceutical research. It aims in particular to guarantee sufficient protection for the development of medicinal products in the European Union (EU).

Indeed, the period between the filing of a patent application for a new medicinal product * and authorisation to place it on the market constitutes one of the factors which actually reduces the effective protection afforded by the patent and can compromise the amortisation of investment in research. The lack of sufficient protection can also lead research centres based in the Member States to relocate to countries offering better protection.

In order to also guarantee the free movement of medicinal products, the supplementary certificate for the protection of medicinal products also aims to prevent the development of too many disparities in national legislation.

The certificate is issued if the product for which it was requested, as a medicinal product and at the time when the application was filed in a Member State, meets the following conditions:

  • the product * is protected by a basic patent * in force;
  • the product, as a medicinal product, has been granted a marketing authorisation;
  • the product has not already been the subject of a certificate;
  • the marketing authorisation is the first authorisation to place the product on the market as a medicinal product.

Furthermore, the certificate applies to the product in the same way as the patent from which it benefits. The Regulation also specifies the arrangements relating to application for and granting of the certificate and likewise the conditions for lapse, invalidity and publicity of the certificate.

The certificate cannot be granted for a period exceeding five years. Furthermore, the duration of protection afforded by a patent and by the certificate cannot exceed 15 years overall for the holder’s first marketing authorisation.

This Regulation codifies and repeals Regulation (EEC) No 1768/92.

Key terms in the Act
  • Medicinal product: any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or animals.
  • Product: the active ingredient or combination of active ingredients of a medicinal product.
  • Basic patent: a patent which protects a product, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EEC) No 469/2009

6.7.2009

–

OJ L152 of 16.6.2009

Visa Code

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Visa Code

Outline of the Community (European Union) legislation about Visa Code

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Justice freedom and security > Free movement of persons asylum and immigration

Visa Code

Document or Iniciative

Regulation (EC) No 810/2009 of the European Parliament and of the Council of 13 July 2009 establishing a Community Code on Visas (Visa Code).

Summary

The aim of the regulation is to establish the conditions and procedures for issuing visas for short stays in (maximum of three months during any six-month period) and transit through the Member States of the European Union (EU) and the associated states applying the Schengen acquis in full. It applies to nationals of third countries that must be in possession of a visa when crossing the external border of the Union, as listed in Regulation (EC) No 539/2001.

In addition, the regulation lists the third countries whose nationals must hold an airport transit visa for passing through the international transit areas of Member State airports (Annex IV). In urgent cases of mass influx of illegal immigrants, any Member State may extend this requirement to nationals of other third countries.

Procedures and conditions for issuing visas

The Member State that is the sole or the main destination of the visit is responsible for examining the visa application. If the main destination cannot be determined, the Member State of entry into the Union is competent. In the case of transit, the Member State through which the transit takes place or, in case of multiple transits, the Member State of first transit is responsible. Generally, the visa application must be submitted to the consulate of the Member State concerned.

Member States may establish bilateral arrangements for representing each other for the purpose of collecting visa applications or issuing visas. They may also cooperate through co-location or a common application centre.

A visa application may be lodged by the applicant or an accredited commercial intermediary at the earliest three months before the intended visit. When lodging an application, the applicant must appear in person, unless this requirement has been waived. Upon lodging an application, the following must be presented:

  • an application form, as set out in Annex I;
  • a valid travel document;
  • a photograph;
  • supporting documents as set out in Annex II, as well as proof of sponsorship and/or accommodation if requested by the Member State;
  • proof of possession of travel medical insurance, if applicable.

Apart from certain exceptions, the applicant must allow the collection of his/her fingerprints and pay a visa fee. The visa fee may be waived or reduced in individual cases, for example for cultural, foreign and development policy reasons. An external service provider may charge an additional service fee.

After verifying the admissibility of the application, the competent authority must create an application file in the Visa Information System (VIS), following the procedures set out in the VIS Regulation. A further examination of the application must be carried out to verify that the applicant fulfils the entry conditions as set out in the Schengen Borders Code, does not pose a risk of illegal immigration or a threat to the security of the Member State and intends to leave the Member State before the visa expires.

A decision on an admissible application must be taken within 15 calendar days from the date on which it was lodged. In exceptional cases, this time limit may be extended. A decision is taken on whether to issue or refuse a uniform visa or a visa with limited territorial validity or, in case of representation of another Member State, to discontinue the examination in order to transfer the application to the latter’s relevant authorities.

A uniform visa may be issued for one, two or multiple entries with a maximum validity of five years. For a transit visa (including airport transit visa), the period of validity must correspond to the time needed for the transit. A 15-day “period of grace” is usually added. In certain cases, the period of validity of a visa may be extended. Under certain circumstances, the visa may also be annulled or revoked.

A uniform visa or visa with territorial validity does not automatically provide a right of entry to the visa holder.

A visa is refused if the applicant:

  • presents a false travel document;
  • gives no justification for the purpose and conditions of the intended stay;
  • provides no proof of sufficient means of subsistence for the duration of the stay nor for the return to his/her country of origin/residence;
  • has already exhausted the three months of the current six-month period;
  • has been issued an alert in the Schengen Information System (SIS) for the purpose of refusing entry;
  • is considered to be a threat to the public policy, internal security or public health of one of the Member States;
  • provides no proof of travel medical insurance, if applicable;
  • presents supporting documents or statements whose authenticity or reliability is doubtful.

The applicant must be notified of a decision to refuse, annul or revoke a visa with the standard form set out in Annex VI. Such a decision may be appealed in the Member State that took it, in accordance to its national law.

Exceptionally, a visa application may be submitted to the authority responsible for checks on persons at the external border of the Member State of destination. A visa issued at a border crossing point may allow for a stay of maximum 15 days or cover the time needed for a transit.

Application

This regulation amends the VIS Regulation and the Schengen Borders Code. It also repeals Articles 9-17 of the Convention implementing the Schengen Agreement and the Common Consular Instructions.

The regulation applies from 5 April 2010. Articles 32(2) and (3), 34(6) and (7), and 35(7) apply from 5 April 2011.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 810/2009

5.10.2009

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OJ L 243 of 15.9.2009

Administrative burdens: sectoral reduction plans 2009

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Administrative burdens: sectoral reduction plans 2009

Outline of the Community (European Union) legislation about Administrative burdens: sectoral reduction plans 2009

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Enterprise > Business environment

Administrative burdens: sectoral reduction plans 2009

Document or Iniciative

Communication from the Commission to the Council and the European Parliament – “Action Programme for Reducing Administrative Burdens in the EU Sectoral Reduction Plans and 2009 Actions” [COM(2009) 544 final – Not published in the Official Journal].

Summary

As part of the Commission’s ‘Better Regulation Agenda’, an action programme for reducing administrative burdens in the European Union (EU) was presented in 2007. In this action programme the Commission proposed an EU strategy whereby administrative burdens arising from EU legislation would be reduced by 25% by 2012. At the beginning of 2009, the Commission committed to present sectoral reduction plans for 13 identified priority areas and to prepare additional measures to reduce administrative burdens in order to reach the target by 2012.

EU baseline measurement

The Commission undertook an assessment of administrative burdens incurred by businesses in fulfilling EU legal obligations to provide information on their products and activities. This EU baseline measurement identified 486 EU information obligations and more than 10,000 national obligations transposing or implementing the EU obligations, of which more than 700 of the national obligations go beyond EU legal requirements.

The results of the EU baseline measurement showed that a large number of the administrative burdens come from a small number of information obligations in a couple of policy areas such as taxation and company law. This result confirms the Commission’s decision to focus their efforts on a limited number of acts in certain key areas.

The Commission found that in general small and medium-sized enterprises (SMEs) incur a proportionally higher burden due to their lack of access to advanced information and communication technologies and to their lack of in-house specialist staff dealing with regulatory matters. It was therefore concluded that special effort must be made to reduce administrative burdens on SMEs. This is in line with the Small Business Act and its “think small first” principle.

The assessment also showed that about a third of administrative burdens of EU origin result from some EU countries going beyond EU legal requirements and being inefficient in their administrative procedures. Differences in the burdens imposed by national measures in the implementation of EU legislation suggest that an exchange of best practice would reduce administrative burdens in many EU countries.

Reduction target for EU legislation

The Commission has already identified potential areas for reductions of burdens that would go beyond the target of 25% reduction by 2012. Measures already adopted could result in a reduction exceeding EUR 26 billion, and measures proposed but yet to be adopted could add EUR 12 billion to that sum. Together with further reductions which are currently under preparation this could lead to a total reduction of EUR 40.4 billion which represents a 33% reduction of administrative burdens of EU origin.

Where the reduction measures are mainly addressed to EU countries as opposed to the EU as a whole, the Commission is responsible for facilitating the changes.

Since the start of the legislature, the European Parliament and the Council have already adopted numerous legislative proposals in all priority areas and the Commission has also put in place several measures for further reduction.

As well as focussing on areas which impose significantly larger administrative burdens, such as taxation and company law, the Commission has also concentrated on allowing enterprises to make the best possible use of the cost saving potential of new technologies and e-government solutions, thereby lightening the burden on SMEs.

Progress at national level

All EU countries have agreed to set individual national reduction targets to eradicate unnecessary administrative burdens. In this communication, the Commission emphasise the need to maintain EU countries’ individual efforts because businesses will only receive the benefits of EU action if their national authorities do their part in reducing administrative burdens of national origin.

Conclusions

Through further consultation and examination, the Commission has identified additional areas of potential reduction which would either extend the scope of the existing 13 priority areas or add new areas to the action programme.

The Commission will continue in its efforts by:

  • proactively reviewing existing legislation to ensure that unnecessary obligations are removed;
  • ensuring that any new policies introduced do not impose more administrative burdens than necessary.