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CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU. When is CE marking mandatory. CE marking is only obligatory for products for which EU specifications exist and require the affixing of CE marking. Some products are subject to several EU requirements at the same time.

You must make sure that your product complies with all the relevant requirements before affixing the CE marking to it. It is forbidden to affix the CE marking to products for which EU specifications do not exist or do not require the affixing of CE marking. How to obtain CE marking. As the product s manufacturer, you bear sole responsibility for declaring conformity with all requirements. You don t need a license to affix the CE marking to your product, however, before doing so, you must.

ensure conformity with all relevant EU-wide requirements determine whether you can assess your product by yourself or if you have to involve a notified body put together a technical dossier documenting conformity find out about technical documentation draft and sign an EU declaration of conformity. Once your product bears the CE marking if the competent national authority requests you must provide them with all the information and supporting documentation concerning CE marking.

You need to check if your product has to be tested by a notified body. Do you need an independent assessment. You can find this information in the relevant legislation applicable to your product check the rules by product category. This step is not obligatory for all products. If you need to involve a notified bodythe CE marking must be accompanied by the identification number of the notified body.

You can use the Nando database to search iq option x ios a notified body that can certify your product. The CE mark and the identification number can be affixed separately, as long as they appear clearly linked to each other. If your product doesn t need to be verified by an independent bodythen it is up to you to check that it complies with the technical requirements. For more information, you can also check with national contact points for medical devices.

This includes estimating and documenting the possible risks when using your product. Do you need to pay any fees. How do you affix the CE marking. The cost depends on which certification procedure that applies to your product and the complexity of the product etc. The CE marking must be visiblelegible and indelible. The CE marking must consist of the initials CEboth letters should have the same vertical dimension and be no smaller than 5mm unless specified differently in the relevant product requirements.

If you as a manufacturer carry out the conformity assessment yourself, you won t have to pay any fees. However, if you opt to use the services of a notified bodyor if the EU specifications applicable to your product require the independent assessment by a notified body, then you must pay the notified body for the service they provide. If you wish to reduce or enlarge the CE marking on your product, you should respect the proportions of the two letters.

As long as the initials remain visible, the CE marking can take different forms for example colour, solid or hollow. If the CE marking cannot be affixed to the product itselfyou can affix it to the packaging if there is any, or to any accompanying documents. If your product is subject to several EU directives regulations which require a CE marking to be affixed, the accompanying documents must indicate that your product conforms to all applicable EU directives regulations.

You can download the CE marking image files from the DG GROW portal. For enterprises entrepreneurs. EU Ecolabel Selling goods and services Selling products in the EU. For consumers employees. EU regulation on product requirements and market surveillance EU decision on a common framework for the marketing of products. Your Product Contact Point can inform you on national product legislation and help you access another national market in the EU.

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You can, however, compare BTECs with GCSEs and A levels in terms of their level, size and content. You can also compare our BTEC Level 3 Nationals in terms of the number of UCAS points they receive. BTEC qualifications are written to a framework and assigned a level based on the relative difficulty of the course. Comparing our qualifications. Qualifications at the same level and on the same framework are similar in their demand, but their size and content may be significantly different. Our BTEC Firsts and new BTEC Tech Awards are designed to be of a similar level of demand to GCSEs, whereas our BTEC Nationals are designed to be of a similar level of demand to A levels.

Comparing the size of a BTEC to other qualifications. For qualifications accredited to the Regulated Qualifications Framework RQFthe size of the course is measured in Guided Learning Hours GLH. This is the number of hours teaching time required to deliver the course. For qualifications accredited to the Qualifications and Credit Framework QCFthe size of the course is measured in credits, where each credit represents 10 hours of notional learning time.

You can find out how many credits or GLHs make up your qualification by checking the course specification or searching the Ofqual register of accredited qualifications. GCSEs are accredited to the NQF at Level 1 Level 2 and require 120 GLH A levels are accredited the NQF at Level 3 and requires 360 GLH. Please note iqoptions. Contact iqoption Contact Us About Us details IQOptions Trade. Official IQ Option contact details. For most up to date information please visit iqoption.

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We no longer sell travel insurance to new customers, but if you have an existing policy don t worry, you re still covered. If you need medical assistance, or to make a claim, here are the numbers to use. 24-hour Emergency Services. 44 20 8239 3902 when calling from outside the UK. 020 8239 3902 when calling from within the UK. 0844 463 02 02 Lines open Monday-Friday, 8am-6pm. If you have any questions about your policy, please call Customer Service 0844 463 02 02.

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Bouton d ouverture du menu. Home About us About us What s new. All News EDQM s response to Covid-19 The EDQM s response to nitrosamine contamination Past News All Events Management Systems Quality Safety Contact us Media enquiries Contact details How to visit the EDQM About EDQM Vision, Mission Values History Structure Call for tenders Employment Why join the EDQM. What we look for in you Employment opportunities Find Information on Memoranda of Understanding and Agreements Quality Management QM Documents ISO 9001 Certificate ISO 17025 EDQM Newsletter FAQ Helpdesk European Pharmacopoeia European Pharmacopoeia What s new.

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You are here Home. In 2018, certain types of nitrosamines N nitrosodiethylamine NDEA and N-nitrosodimethylamine NDMA were detected in a number of active substances used in the treatment of hypertension and in related medicines. Nitrosamines are known as possible carcinogens for humans only very low amounts are acceptable according to current regulatory requirements ICH M7 cohort of concern. Their detection requires highly sensitive analytical methods.

As clarified by the European Medicines Agency EMAtheir presence in active substances may be linked to several factors, e. from processing conditions to accidental introduction due to cross-contamination from processes running in parallel on the same production lines or recovery procedures for solvents, or also from degradation of the substances. A Directorate of the Council of Europe created in 1964. Also develops guidance and standards in the areas of blood transfusion, organ transplantation and consumer health issues.

Main objective is to provide common quality standards to control the quality of medicines and of substances used in the manufacture of medicines human and veterinary use. Legally binding in European member states. 39 signatory parties including the EU and 30 observers including WHO and TFDA as of March 2018. A leading organisation that protects public health by enabling the development, supporting the implementation and monitoring the application of quality standards for safe medicines and their safe use.

Around 70 laboratories provide human and technical resources to implement testing programmes. 36 European countries and 5 countries outside Europe participate in the various activities and programmes. Established in 1994. A network of independent public laboratories appointed by the national authorities. Over 4,900 certificates covering more than 1,100 substances have been granted in more than 60 countries. Assessment is jointly performed by a network of around 100 assessors from the national competent authorities and EDQM assessors.

Organises an inspection programme involving a network of around 30 inspectors from 20 different national competent authorities and the EDQM. Availability of and access for patients to quality medicines is more important than ever in the context of the current COVID-19 pandemic. The EDQM s core activities include the provision of documentary and physical reference standards to ensure the quality of medicines and their ingredients.

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EDQM Council of Europe7 allée Kastner, CS 30026, F-67081 Strasbourg, France, Tel. 33 3 88 41 30 30 Fax 33 3 88 41 27 71. Emmanuel Macron accuses Dutch of acting like Brexit Britain at EU coronavirus summit. French president snapped as talks over 750bn coronavirus economic stimulus package enter their fourth day. Emmanuel Macron accused the prime minister of the Netherlands of taking Brexit Britain s obstructive role at EU summits, as marathon talks over a massive coronavirus rescue fund stretched into a fourth straight day on Monday.

The French President s patience snapped as tempers flared in tough negotiations over the plans for a 750 bn coronavirus stimulus package and bolstered 1. 1 trillion EU Budget for seven years from 2021. The package is backed by France, Germany, Spain, Italy and others but resisted by the frugal four of the Netherlands, Austria, Sweden and Denmark, who were joined by Finland on Sunday.

Mark Rutte, the prime minister of the Netherlands and his allies have demanded more oversight of payments from the rescue fund, more of the cash to be loans rather than non-repayable grants and for the Budget to be slimmed down. Mr Macron accused Mr Rutte of behaving like David Cameron, the former British prime minister who would often boast of battling for Britain in Brussels. Mr Cameron s strategy of taking a hard line in summits for domestic political gain ended badly with him losing the Brexit referendum and his job, Mr Macron told Mr Rutte last night.

Before threatening to walk from the talks rather than make a bad deal, Mr Macron bashed the table and attacked Sebastian Kurz for leaving the negotiations to take a phone call. The Austrian chancellor was described as offended by one source after Mr Macron said, You see. He doesn t care. He doesn t listen to others. A French source said accounts of the outburst were a little caricatured but said Mr Macron had taken a hard line on their inconsistencies. The Dutch prime minister, whose conservative VVD party faces a strong challenge from far-right eurosceptic parties in elections next March, said on Monday morning that on the whole progress was being made at the near record length summit.

We re not here to be invited to each other s birthdays for the rest of our lives, he said. His ally Sebastian Kurz appeared to claim victory for their frugals. Hard negotiations have just come to an end, we can be very satisfied with today s result, the Austrian Chancellor tweeted, We ll continue in the afternoon. Charles Michel, the president of the European Iq option x ios, addressed the exhausted leaders briefly at about 5.

45am on Monday morning before talks broke up until 4pm. He said earlier that more than 600,000 people had died as a result of the coronavirus and called on the divided heads of state and government to unite to accomplish mission impossible. That is my heartfelt wish, he said at their third dinner in a row, which, rather than the ostentatious fare usually served, was a cold plate. The summit of the 27 EU leaders began Friday and was scheduled to end Saturday.

Angela Merkel and Mr Macron, the bloc s two most influential leaders, walked out of heated talks before dawn Sunday with the frugals, bemoaning their lack of commitment to a common cause. They ran off in a bad mood, Mr Rutte said. Leaders are under pressure to respond to the devastating economic impact of the coronavirus lockdowns at their first face to face summit since the pandemic hit in March.

While they could call another summit to agree the rescue plan, they fear a second wave could force further talks back online after previous virtual summits also failed. The recovery fund would be raised by the European Commission against the Budget on behalf of the member states, which would bust a long-standing taboo against raising common debt and be a historic step towards greater integration. Germany and France, with the backing of most of the bloc, are insistent that at least 400 billion of the package must be handouts rather than loans in order to shield the fragile economies of southern Europe from the worst effects of the coronavirus pandemic.

Mr Rutte and his fiscally conservative group say that figure must be substantially less and more money should be disbursed in the form of loans. The frugals see 350 billion euros as the maximum. Discussions over grants have narrowed with Mr Michel saying they 390 billion euros combined with smaller rebates on EU Budgets. Countries that receive rebates to their Budgets, which include the Netherlands, have insisted they are preserved, despite the UK rebate falling away after Brexit.

Mr Rutte wants member states to retain an effective veto over EU funding for recovery plans for the likes of hard-hit Spain and Italy. This would oblige them to reform their labour markets to be more resilient for future crises, he claimed. The recovery plan cannot become a tool to carry on an ideological battle, Italian Prime Minister Giuseppe Conte, who supports the massive fund to kickstart the economy, He can t ask us to do specific reforms.

Mr Conte accused the frugal states of blackmailing Europe and warned their resistance risked ultimately destroying the Single Market and the futures of the young. Grants are needed for a swift recovery and to strengthen the resilience of countries which face greater difficulties in having economic growth, he said last night. Hungary, backed by Poland, threatened to veto the package if its disbursement was made dependent on meeting conditions on upholding the rule of law, which is an idea Mr Rutte supports.

I don t like blame games but the Dutchman is the real responsible man for the whole mess, Hungary s Viktor Orban told reporters on Sunday, The Dutch prime minister, he is the fighter. European Council Summit, European Council, Brexit, Emmanuel Macron, Coronavirus, Netherlands. Live Coronavirus latest news EU pushes single quarantine rule for travel. Disunited Nations - how Covid quarrels have spoiled the UN s 75 birthday. Pictures of the Day 15th September 2020.

15 Sep 2020, 6 31am. Whistleblower nurse alleges hysterectomies performed on immigrant women in US. Irritable heart attack victims more likely to die from second attack, study finds. Prisoners are making unmonitored phone calls after telephones were installed in their cells.

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