processing is necessary for the purposes of complying with the specific rights and obligations of the controller in the field of employment law insofar as it is authorised by the Treaties establishing the European Communities or other legal instruments adopted on the basis thereof, or, if necessary, insofar as it is agreed upon by the European Data Protection Supervisor, subject to adequate safeguards, or

The adaptation to scientific and technical progress of the requirements for treatment facilities and for the use of hazardous substances and, as well as the adoption of minimum standards for the certificate of destruction, the formats for the database and the implementation measures necessary to control compliance with the quantified targets should be effected by the Commission under a Committee procedure.

For the purposes of applying Community aid schemes not covered by this Regulation and notwithstanding the specific provisions laid down under such schemes, in particular those concerning the terms under which aid may be granted, the Member States may incorporate in their administration and control mechanisms one or more of the administrative, technical or data-processing components of the integrated system.

Analysis of long-term data from study 006 (median follow-up 180 weeks, 102 weeks, and 76 weeks for patients treated with efavirenz + zidovudine + lamivudine, efavirenz + indinavir, and indinavir + zidovudine + lamivudine, respectively) showed that, beyond 24 weeks of therapy, the incidences of new-onset nervous system symptoms among efavirenz-treated patients were generally similar to those in the control arm.

In EBC, the following patients were excluded from the HERA trial, there are no data about the benefit: risk balance, and therefore treatment can not be recommended in such patients: • History of documented CHF • High-risk uncontrolled arrhythmias • Angina pectoris requiring medication • Clinically significant valvular disease • Evidence of transmural infarction on ECG • Poorly controlled hypertension

Analysis of long-term data from a clinical study (median follow-up 180 weeks, 102 weeks and 76 weeks for patients treated with efavirenz + zidovudine + lamivudine, efavirenz + indinavir, and indinavir + zidovudine + lamivudine, respectively) showed that, beyond 24 weeks of therapy, the incidences of new-onset nervous system symptoms among efavirenz-treated patients were generally similar to those in the control arm.

Whereas the provisions on the integrated administration and control system for certain Community aid schemes as laid down by Council Regulation (EC) No 3508/92 (6), as last amended by Regulation (EC) No 820/97 (7), and Commission Regulation (EEC) No 3887/92 (8), as last amended by Regulation (EC) No 2015/95 (9), do not contain specific rules on the final date for submitting surface aid applications for the rice sector;

1) There are important outstanding issues regarding the differences of production and control between the manufacturing sites (including the nature of the eggs used), the lack of a validation study for the potency test on finished product (it appears that final product tests are only done at Weesp but in-process tests such as titration and HA quantification need to be equivalent too) and the lack of any stability data.

Within five years of the date of the entry into force of this paragraph, the Parties shall determine the feasibility of banning or restricting, from States not party to this Protocol, the import of products produced with, but not containing, controlled substances in Annex B. If determined feasible, the Parties shall, following the procedures in Article 10 of the Convention, elaborate in an annex a list of such products.

Without prejudice to paragraph 1, a Member State may authorize a transfer or a set of transfers of personal data to a third country which does not ensure an adequate level of protection within the meaning of Article 25 (2), where the controller adduces adequate safeguards with respect to the protection of the privacy and fundamental rights and freedoms of individuals and as regards the exercise of the corresponding rights;

It is therefore appropriate to provide for a step-by-step approach to further market-opening, consisting of intermediate steps representing significant but controlled opening of the market, followed by a review and proposal confirming, if appropriate, the date of 2009 for the full accomplishment of the internal market for postal services or determining a relevant alternative step towards it in the light of the review results.

detailed rules for the application of Article 2a including any derogation from the relevant regulations and Regulation (EEC) No 3508/92(14), which are necessary to achieve the aim of simplification, notably those related to eligibility conditions, dates of application and payment and control provisions as well as detailed rules in order to avoid double claims in respect of the area and production covered by the simplified scheme,

without prejudice to Member States' obligations with regard to transmission of information under the provisions of the United Nations Conventions on drugs, promote the incorporation of data on drugs and drug addiction gathered in the Member States or emanating from the Community into international monitoring and drug-control programmes, particularly those established by the United Nations Organization and its specialized agencies;

This Decision establishes a common technical regulation covering the technical characteristics (electrical and mechanical interface requirements and access control protocol) to be provided by terminal equipment using a CCITT Recommendation X.21 interface, or at an interface physically, functionally and electrically compatible with CCITT Recommendation X.21 but operating at any data signalling rate up to, and including, 1 984 kbit/s.

Describe statistical evaluation programmes for data accumulated in control programmes for weight, volume, sampling and analytical measurements (i.e. determination of the random and systematic errors of the measurements and associated limits of error); statistical methods used to combine individual measurement error estimates to obtain the overall limits of error for S/R differences, the book inventory, the physical inventory and MUF.

The Community shall not submit the import of wine originating in Canada to a more restrictive or more widespread system of certification than that which applies on the date of entry into force of this Agreement, and that which may be applied to wines imported from other countries applying equivalent supervision and control measures, other than temporary additional certification requirements in response to legitimate public policy concerns.

Within three years of the date of the entry into force of this paragraph, the Parties shall, following the procedures in Article 10 of the Convention, elaborate in an annex a list of products containing controlled substances in Annex B. Parties that have not objected to the annex in accordance with those procedures shall ban, within one year of the annex having become effective, the import of those products from any State not party to this Protocol.

The notice is based on experience gained by the Commission in applying Council Regulation (EEC) No 4064/89 of 21 December 1989 on the control of concentrations between undertakings(1), as last amended by Regulation (EC) No 1310/97(2) (the "Merger Regulation") to date, which has shown that certain categories of notified concentrations are normally cleared without having raised any substantive doubts, provided that there were no special circumstances.

For substances included in the first list of priority substances, in the absence of agreement at Community level six years after the date of entry into force of this Directive, Member States shall establish environmental quality standards for these substances for all surface waters affected by discharges of those substances, and controls on the principal sources of such discharges, based, inter alia, on consideration of all technical reduction options.

All transplant patients are at increased risk of opportunistic infections; the risk increased with total immunosuppressive load (see section 4.4) The most common opportunistic infections in patients receiving CellCept (2 g or 3 g daily) with other immunosuppressants in controlled clinical trials of renal (2 g data), cardiac and hepatic transplant patients followed for at least 1 year were candida mucocutaneous, CMV viraemia/ syndrome and Herpes simplex.

effective powers of intervention, such as, for example, that of delivering opinions before processing operations are carried out, in accordance with Article 20, and ensuring appropriate publication of such opinions, of ordering the blocking, erasure or destruction of data, of imposing a temporary or definitive ban on processing, of warning or admonishing the controller, or that of referring the matter to national parliaments or other political institutions,

Within three years of the date of entry into force of this paragraph, the Parties shall, following the procedures in Article 10 of the Convention, elaborate in an annex a list of products containing controlled substances in Group II of Annex C. Parties that have not objected to the annex in accordance with those procedures shall ban, within one year of the annex having become effective, the import of those products from any State not party to this Protocol.'

Whereas Article 4 of the Council Directive of 20 July 1970 on the introduction of Community methods of sampling and analysis for the official control of feedingstuffs provides that the procedure for this introduction laid down in Article 3 of that Directive must terminate within eighteen months following the date on which a matter is first referred to the Standing Committee for Feedingstuffs either under Article 3 (1) or under any other corresponding provision;

Member States shall ensure that the use of electronic communications networks to store information or to gain access to information stored in the terminal equipment of a subscriber or user is only allowed on condition that the subscriber or user concerned is provided with clear and comprehensive information in accordance with Directive 95/46/EC, inter alia about the purposes of the processing, and is offered the right to refuse such processing by the data controller.

has sound administrative and accounting procedures, control and safeguard arrangements for electronic data processing and adequate internal control mechanisms including, in particular, rules for personal transactions by its employees or for the holding or management of investments in financial instruments in order to invest own funds and ensuring, inter alia, that each transaction involving the fund may be reconstructed according to its origin, the parties to it, its nature, and the time and place at which it was effected and that the assets of the unit trusts/common funds or of the investment companies managed by the management company are invested according to the fund rules or the instruments of incorporation and the legal provisions in force;

Surveillance data processing systems shall be designed, built, maintained and operated using the appropriate and validated procedures, in such a way as to provide the required performance and quality of service within a given environment (surface, TMA, en-route) with known traffic characteristics, in particular in terms of accuracy and reliability of computed results, correctness, integrity, availability, continuity and timeliness of information at the control position.

By way of derogation from Articles 8, 9(1), 10, 11(2) and (3), trade with any State not party to the Protocol in controlled substances and products which contain or are produced by means of one or more such substances may be authorised by the Commission, to the extent that the State not party to the Protocol is determined by a meeting of the Parties to be in full compliance with the Protocol and has submitted data to that effect as specified in Article 7 of the Protocol.

37 Clinical experience Efficacy of PREZISTA co-administered with 100 mg ritonavir in ART-naïve patients The evidence of efficacy of PREZISTA/ritonavir 800/100 mg q.d. is based on the analyses of 48 week data from the ongoing, randomised, controlled, open-label Phase III trial ARTEMIS in antiretroviral treatment-naïve HIV-1 infected patients comparing PREZISTA/ritonavir 800/100 mg q.d. with lopinavir/ritonavir 800/200 mg per day (given as a twice-daily or as a once-daily regimen).

"Time-modulated ultra-wideband" means the technique in which very short precisely time-controlled RF pulses are modulated in accordance with communications data by shifting pulse positions (usually called Pulse Position Modulation, PPM) channelised or scrambled in accordance with pseudo-random noise codes by PPM, then transmitted and received in the direct pulse form without using any carrier frequencies, consequently having extremely low power density over ultra-wide frequency bands.

Consistent with clinical study data on the timing of fever and measles-like rash, an analysis of a post-marketing observational safety study in children (N=31,298, 99 % in their second year of life) receiving their first dose of vaccine has shown that febrile seizures occurred more frequently 5-12 days following vaccination with ProQuad (n=22; 0.7 per 1000 children) when compared with data from children in a historical, age- and gender- matched, control group vaccinated with the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., and the Varicella Vaccine live (Oka/ Merck) concomitantly (N=31,298) before ProQuad was available (n=10; 0.3 per 1000 children).

As a result of the date of entry into force of Regulation (EC) No 2136/2001 the Commission was unable to fix the maximum amount of the Community financial participation for 2002 in accordance with Commission Regulation (EC) No 1780/97 of 15 September 1997 laying down detailed rules for the application of Council Regulation (EC) No 723/97 on the implementation of Member States' action programmes on control of EAGGF Guarantee Section expenditure(3), as last amended by Regulation (EC) No 1890/98(4).

Describe methods of statistical evaluation of data accumulated in measurement control programmes for the evaluation of precision and accuracy of measurements and the estimation of measurement uncertainty (i.e. determination of the random and systematic errors of the measurements and the associated limits of error; statistical procedures used to combine individual measurement error estimates to obtain the overall limits of error for S/R differences, the book inventory, the physical inventory and MUF).

detailed rules related to the granting of aids provided for in this Regulation, including eligibility conditions, dates of application and payment and control provisions as well as checking and establishing entitlement to the aids including any necessary exchange of data with the Member States, and the establishment of the overrun of the base areas or maximum guaranteed areas as well as detailed rules concerning the withdrawal and reallocation of unused premium rights established under Chapter 11 and 12;

In particular, the competent authorities of the home Member State, having regard also to the nature of the investment company, shall require that the company has sound administrative and accounting procedures, control and safeguard arrangements for electronic data processing and adequate internal control mechanisms including, in particular, rules for personal transactions by its employees or for the holding or management of investments in financial instruments in order to invest its initial capital and ensuring, inter alia, that each transaction involving the company may be reconstructed according to its origin, the parties to it, its nature, and the time and place at which it was effected and that the assets of the investment company are invested according to the instruments of incorporation and the legal provisions in force.";

On the basis of the data collected, the Agency shall assist the Commission in the publication, every six months, of information relating to ships that have been refused access to Community ports pursuant to Council Directive 95/21/EC of 19 June 1995 concerning the enforcement, in respect of shipping using Community ports and sailing in the waters under the jurisdiction of the Member States, of international standards for ship safety, pollution prevention and shipboard living and working conditions (port State control)(8).

These improvements may be obtained by reducing steering control effort, inserting requirements for power-assisted steering equipment using the same energy source as the braking device, introducing a steering test at higher speed for motor vehicles, introducing requirements for auxiliary steering equipment, and introducing a uniform presentation for the information document and the EEC type-approval certificate in order to facilitate computerization of storage and transmission of data by applicants and approval authorities;

In order to ensure that the aid scheme is properly applied, producer organisations and processors must forward the necessary information and keep up-to-date suitable documentation and should, in particular, specify the areas under tomatoes, peaches and pears, on the basis of Council Regulation (EEC) No 3508/92 of 27 November 1992 establishing an integrated administration and control system for certain Community aid schemes(9), as last amended by Commission Regulation (EC) No 495/2001(10), and Commission Regulation (EC) No 2419/2001 of 11 December 2001 laying down detailed rules for applying the integrated administration and control system for certain Community aid schemes established by Council Regulation (EEC) No 3508/92(11), as last amended by Regulation (EC) No 2550/2001(12), for the purposes of all inspections and controls deemed necessary.

Methods of analysis, detection and control: The objective is to contribute to the development, improvement, validation and harmonisation of reliable and cost-effective sampling and measurement strategies for chemical contaminants and existing or emerging pathogenic micro-organisms (such as viruses, bacteria, yeasts, fungi, parasites, and new agents of the prion type including development of ante mortem diagnostic tests for BSE and scrapie) so as to controll the safety of the food and feed supply and ensure accurate data for risk analysis.

Assessment of adverse reactions from clinical study data is based on experience in two studies in 653 treatment-experienced patients receiving treatment with tenofovir disoproxil fumarate (n = 443) or placebo (n = 210) in combination with other antiretroviral medicinal products for 24 weeks and also in a double-blind comparative controlled study in which 600 treatment-naïve patients received treatment with tenofovir disoproxil 245 mg (as fumarate) (n = 299) or stavudine (n = 301) in combination with lamivudine and efavirenz for 144 weeks.

The competent authority shall only accept the application referred to in the third paragraph on condition that it includes a commitment by the person concerned to pay to the competent authority a sum equal to the securities released if it is discovered, during any control that the public authorities may carry out during the 12 months following the date of signature of the commitment, that the caseins or caseinates concerned had a destination other than that indicated in the supporting documents submitted in accordance with the third paragraph.

Although moxifloxacin has shown to be effective, the available data is limited as studies have been mainly performed against comparators and the only placebo controlled study failed to demonstrate statistical superiority over placebo. Considering the higher incidence of serious and even life-threatening risks in the treatment of an infection which has a high spontaneous resolution rate without antibiotics was considered of concern. However, the benefit risk of moxifloxacin may be favourable if other antibiotherapy has failed or cannot be used.

An investor other than a natural person which has the nationality of a Contracting Party party to the dispute on the date of the consent in writing referred to in paragraph 4 and which, before a dispute between it and that Contracting Party arises, is controlled by investors of another Contracting Party, shall for the purpose of Article 25 (2) (b) of the Icsid Convention be treated as a 'national of another Contracting State` and shall for the purpose of Article 1 (6) of the Additional Facility Rules be treated as a 'national of another State`.

Whereas in the absence of these guarantees for the abovementioned date and in view of facilitating to the new system of veterinary controls at the external borders of the Community, it is necessary to draw up provisional Community lists of third countries or parts of third countries from which imports of semen, ova and embryos of the ovine, caprine and equine species, ova and embryos of the porcine species are authorized, which could be based, in particular, on Council Decision 79/542/EEC (2), as last amended by Commission Decision 93/507/EEC (3);

Flash point Surface tension Explosive properties Oxidizing properties Reactivity towards container material Further information on the active substance Function, e.g. fungicide, herbicide, insecticide, repellant, growth regulator Effects on harmful organisms, e.g. contact poison, inhalation poison, stomach poison, fungitoxic or fungistatic, etc., systemic or not in plants Field of use envisaged, e.g. field, glasshouse, food or feed storage, home garden Where necessary, in the light of the test results, any specific agricultural, plant health or environmental conditions under which the active substance may or may not be used. Harmful organisms controlled and crops or products protected or treated Mode of action Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies Recommended methods and precautions concerning handling, storage, transport or fire In case of fire, nature of reaction product, combustion gases, etc. (;) These data must be submitted for the purified active substance of stated specification. ($) These data must be submitted for the active substance and the purified active substance of stated specification. Emergency measures in the case of an accident Procedures for destruction or decontamination of the active substance Possibility of recovery Possibility of neutralization Controlled discharge Controlled incineration Water purification Others Analytical methods

For the purpose of rapid and accurate tracing of animals for reasons relating to the control of Community aid schemes, each Member State should create a national computerised data base which will record the identity of the animal, all holdings on its territory and the movements of the animals, in accordance with the provisions of Council Directive 97/12/EC of 17 March 1997 amending and updating Directive 64/432/EEC on health problems affecting intra-Community trade in bovine animals and swine(12), which clarifies the health requirements concerning this database.

Basiliximab has been tested in four randomised, double-blind, placebo-controlled studies in renal transplant recipients as an induction agent in combination with the following immunosuppressive regimens: ciclosporin for microemulsion and corticosteroids in two studies (346 and 380 patients), ciclosporin for microemulsion, azathioprine and corticosteroids in one study (340 patients), and ciclosporin for microemulsion, mycophenolate mofetil and corticosteroids in another study (123 patients). Safety data in paediatric patients have been obtained from one open-label

When a taxable person stores invoices which he issues or receives by an electronic means guaranteeing on-line access to the data and when the place of storage is in a Member State other than that in which he is established, the competent authorities in the Member State in which he is established shall have a right, for the purpose of this directive, to access by electronic means, download and use these invoices within the limits set by the regulations of the Member State where the taxable person is established and as far as that State requires for control purposes."

Description To further support the benefit risk assessment, the MAH has provided the CHMP with the 48-week safety and efficacy data from the ongoing Phase III Protocol 018 (A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV- Infected Patients With Documented Resistance to at Least 1 Drug in Each of the 3 Classes of Licensed Oral Antiretroviral Therapies) and Protocol 019 (A Multicenter, Double-Blind, Randomized, Placebo- Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV-Infected Patients With Documented Resistance to at Least 1 Drug in Each of the 3 Classes of Licensed Oral Antiretroviral Therapies) for review.

Farmers should be entitled to amend their area aid applications until the latest date for sowing in accordance with Council Regulation (EC) No 1251/1999 of 17 May 1999 establishing a support system for producers of certain arable crops(7), as last amended by Regulation (EC) No 1038/2001(8), provided that all the particular requirements under the relevant sectoral rules are respected and that the competent authority has not yet informed the farmer of errors contained in the aid application, nor notified an on-the-spot control which reveals errors, in relation to the part affected by the amendment.

The provisions referred to in Annex A und Annex B, as well as those already adopted pursuant to Article 2(3), shall be put into effect for Iceland and Norway on a date to be fixed by the Council acting by unanimity of its Members representing the Member States which participate in the closer cooperation authorised by the Schengen Protocol, after consultations in the Mixed Committee in accordance with Article 4 of this Agreement, having satisfied itself that the preconditions for the implementation of the relevant provisions have been fulfilled by Iceland and Norway and that controls at their external borders are effective.