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Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period. The titles of all other Acts are printed in bold type and preceded by an asterisk. The strictest control and monitoring measures apply to substances of category 1. For example, substances of category 1 need to be stored in secured premises and each operator dealing with such substances needs a licence. In other words, those substances can be easily transformed into MDMA or amphetamines. The misuse and abuse of MDMA and amphetamines are causing serious social and public health problems in some regions of the Union. Large quantities of MDMA and amphetamines are also exported to third countries. Red phosphorus is frequently diverted from trade in the internal market and used in the Union for the illicit manufacture of methamphetamine. Methamphetamine is a very addictive drug which is causing serious social and public health problems in some regions of the Union. Red phosphorus has however important and diversified legal uses, such as the manufacture of flame-retardants for plastics, pyrotechnics and striker plates for safety matches and flares. The purpose of that Annex is to avoid unduly hampering legitimate trade in those substances in cases where it is possible to reduce or eliminate the risk of diversion into illicit channels by limiting the restrictions on trade to quantities over a certain threshold. Based on available evidence and consultations with the competent authorities of the Member States, that threshold for red phosphorus should be set at 0,1 kg. Given that there is important lawful production, trade and use of red phosphorus in the Union, economic operators and competent authorities should be given sufficient time to adapt to the new restrictions concerning that substance introduced by this Regulation. In view of the close material link between those two Regulations, it is justified to adopt the amendments by way of one single delegated act,. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. CN designation if different. CN Code. CAS No. Alpha -phenylacetoacetamide APAA. On behalf of the President,. Member of the Commission. Following discussions between the Union and the United Kingdom, an agreement on new quantities for four tariff quotas in the rice sector was reached. It is therefore also appropriate to amend the quantities for tariff quotas under order numbers It is therefore appropriate to amend the quantity and CN codes of the tariff rate quota under order number To ensure legal certainty and in order for the revised quantities of the tariff rate quotas to apply to the licence applications that may be submitted for tariff quotas with a tariff quota period starting on 1 January , this Regulation should enter into force as a matter of urgency on the day following that of its publication in the Official Journal of the European Union. The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,. This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. International agreement or other act. Tariff quota period. Tariff quota sub-periods. Licence application. Product description. Meat and edible offal of poultry, fresh, chilled or frozen; other prepared or preserved meat of turkeys and of fowls of the species Gallus domesticus. Proof of origin at licence application. If yes, body authorised to issue it. Proof of origin for release into free circulation. Quantity in kilograms. CN codes. In-quota customs duty. Proof of trade. Security for import licence. Specific entries to be made on the licence application and on the licence. Period of validity of a licence. Transferability of licence. Reference quantity. Operator registered in LORI database. Specific conditions. It is appropriate to set out new provisions necessary for the implementation of the renewal procedure, in particular the periods for the different steps of the renewal procedure. Those include, amongst others, the provision of pre-submission advice on intended tests and studies for the purposes of a renewal, preceded by a specific notification by the potential applicant and consultation of third parties, the provision of general pre-submission advice on the rules applicable to the application for renewal, and its content, a notification obligation imposed on business operators, laboratories and testing facilities when studies are commissioned or carried out by them to support an application, the public disclosure of all scientific data, studies and other information supporting an admissible application by the Authority, and a consultation of third parties on the submitted scientific data, studies and other information supporting an admissible application. To ensure proper implementation of those provisions in the context of the procedure for the renewal of approval of active substances, detailed rules should be set out. An application for renewal should include the necessary data and risk assessments and demonstrate why any new data and risk assessments are necessary. Consequently, it is necessary to adopt a standard data format. Rules should be set out as regards the establishment of the admissibility of the application for renewal by the rapporteur Member State. Where all applications for renewal submitted are inadmissible, the Commission should adopt a Regulation on the non-renewal of the active substance concerned to provide clarity on the status of the active substance. To ensure a proper implementation of those requirements, the conditions for the assessment of confidentiality requests in the context of applications for renewal should be set out. The applicant, the Member States, with the exception of the rapporteur Member State, and the public should be given the opportunity to submit comments on the draft renewal assessment report prepared by the rapporteur Member States and co-rapporteur Member State, or by Member States acting jointly as rapporteur. The Authority should organise consultations of experts and provide conclusions, except where the Commission informs it that a conclusion is not necessary. Rules should be set out as regards the renewal report and the adoption of a regulation on the renewal or non-renewal of the approval of the active substance. Transitional measures should be provided for active substances for which the approval period ends before 27 March to ensure that the renewal procedure for those substances can continue. The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,. This Regulation shall apply to the renewal of the approval of active substances whose approval period ends on or after 27 March A potential applicant may request from the staff of the Authority general pre-submission advice at any time before the submission of the application for renewal. The Authority shall inform the rapporteur Member State of the request and together they shall decide if the co-rapporteur Member State is required to participate in providing the general pre-submission advice. Where several potential applicants request general pre-submission advice, the Authority shall suggest that they submit a joint application for renewal and disclose their contact details to each other for that purpose. An application for renewal shall be submitted electronically via a central submission system using the format as set out in Article 7 by a producer of the active substance no later than three years before the expiry of the approval. Prior to the expiry of the deadline for submission of the application for renewal, the Member States acting jointly as rapporteur Member State shall agree on the repartition of all tasks and workload. Member States forming part of the group of Member States acting jointly as rapporteur Member State shall endeavour to reach consensus during the evaluation. A joint application for renewal may be submitted by an association of producers designated by the producers. Where there is more than one applicant requesting the renewal of the approval of the same active substance, those applicants shall take all reasonable steps to submit their dossiers jointly. Where contrary to the advice of the Authority as referred to in Article 4 such dossiers are not submitted jointly by all the applicants concerned, the reasons for that shall be set out in the dossiers. An application for renewal shall consist of a renewal dossier in the format as set out in Article 7. The information referred to in point o of the first subparagraph shall be clearly identifiable. The renewal dossier shall not contain any reports of tests or studies involving the deliberate administration of the active substance or the plant protection product containing it to humans. Applicants shall make their best efforts to obtain access to and provide the studies which were part of the approval dossier or subsequent renewal dossiers as required under points e and f of paragraph 2. If the information submitted in accordance with point c of paragraph 2 does not cover all zones or does not concern a widely grown crop, a justification shall be submitted. The uses referred to in point c of paragraph 2 shall, where appropriate, include the uses evaluated for the approval or subsequent renewals. At least one plant protection product referred to in point c of paragraph 2 shall contain no other active substance, where such a product exists for a representative use. The applicant shall identify and list the new data it submits, including any new studies involving vertebrate animals in a separate list. The Authority shall establish and make available online a central submission system. The Authority shall ensure that the central submission system facilitates the verification of admissibility performed by Member States in accordance with Article 8. The Authority shall assess such a request only if the application is considered admissible in accordance with Article 8 of this Regulation. The rapporteur Member State shall consider an application for renewal admissible, provided that all the following requirements are met:. The rapporteur Member State shall, within a period of one month from the date provided for in Article 5 1 , inform the applicant, the co-rapporteur Member State, the Commission and the Authority of the date of receipt of the application for renewal and of its admissibility. Where an application for renewal has been submitted in accordance with point a of paragraph 1, but one or more elements provided for in point b or d of paragraph 1 are missing, the rapporteur Member State shall, within a period of one month from the date of receipt of the application for renewal, inform the applicant which elements are missing and set a period of 14 days for the submission of those elements via the central submission system referred to in Article 7. Upon expiry of that period, the rapporteur Member State shall, without delay, proceed in accordance with either paragraph 4 or paragraph 5. Where the application for renewal does not comply with point c of paragraph 1, the rapporteur Member State shall, in coordination with the Authority, within a period of one month from date of receipt of the application for renewal, inform the applicant accordingly and set a period of 14 days for providing a valid justification for this non-compliance. If that point in time is later than three years before the expiry of the approval of the active substance, the resubmitted application for renewal shall be considered inadmissible. Where the application for renewal has not been submitted within the period referred to in point a of paragraph 1, or where at the end of the day period set for the submission of the missing elements in accordance with paragraphs 3 and 4 the application for renewal still does not contain all the elements provided for in Article 6, the rapporteur Member State shall, without delay, inform the applicant, the co-rapporteur Member State, the Commission, the other Member States and the Authority that the application for renewal is inadmissible and of the reasons for inadmissibility. Public access to the information in the application for renewal and consultation of third parties. This paragraph does not apply to the submission of any supplementary information submitted by the applicant during the evaluation process. The rapporteur Member State shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge using guidance documents applicable at the date of the submission of the application for renewal. It shall take into account all the information submitted as part of the application for renewal, including the dossiers submitted for the approval and subsequent renewals of approval. The rapporteur Member State shall also identify and consider, where appropriate, risk mitigation measures and take into account the written comments received during the public consultation pursuant to Article Where despite the best efforts made the applicant could not submit the full text and summary of each test and study report which were part of the approval dossier or subsequent renewal dossiers and required in accordance with points e and f of Article 6 2 , the rapporteur Member State shall ensure that the respective studies are evaluated and taken into account in their overall assessment. In its assessment, the rapporteur Member State shall first establish whether the approval criteria set out in points 3. Where the rapporteur Member State requires additional information, it shall set a period for the applicant to supply that information. That period shall not lead to an extension of the period of 13 months provided for in paragraph 1. The rapporteur Member State may consult the Authority and request additional technical or scientific information from other Member States. Such consultations and requests shall not lead to an extension of the period of 13 months provided for in paragraph 1. The rapporteur Member State shall duly justify its view that the criteria for classification for one or more of these hazard classes are not fulfilled. Where a proposal for classification of an active substance has already been submitted to the Agency and its assessment is ongoing, the rapporteur Member State shall submit an additional proposal for classification, limited to any hazard classes listed in the first subparagraph that are not covered by the pending proposal unless new information has become available that was not part of the pending dossier as regards those listed hazard classes. The Authority shall examine whether the draft renewal assessment report received from the rapporteur Member State contains all the relevant information in the agreed format and circulate it to the applicant and to the other Member States at the latest three months after its receipt. The Authority shall make the draft renewal assessment report publicly available with the exception of the information for which the confidentiality request has been accepted as justified. The Authority shall allow a period of 60 days from the date the draft report is made available to the public for the submission of written comments. Such comments shall be communicated to the Authority, which shall collate and forward those comments, together with its own comments, to the rapporteur Member States or group of Member States acting jointly as rapporteur Member State and where relevant the co-rapporteur Member State. The Authority shall provide its view to the Commission on whether it is not necessary in the light of the comments received to continue the procedure in accordance with Article The Authority shall make the updated renewal dossier available to the public at the same time as making the draft renewal assessment report available in accordance with Article The Authority shall, where appropriate, organise a consultation of experts, including experts from the rapporteur Member State and co-rapporteur Member State. Where appropriate, the Authority shall address in its draft conclusion the risk mitigation options identified in the draft renewal assessment report or during the peer review. The Commission may inform the Authority without delay after the period referred to in Article 12 3 has expired that a conclusion is not necessary. Where the Authority considers that additional information from the applicant is necessary, it shall, in consultation with the rapporteur Member State, set a period not exceeding one month for the applicant to supply such information to the Member States, the Commission and the Authority. The rapporteur Member State shall, within 60 days from the date of receipt of the additional information evaluate the information received and send its evaluation to the Authority. Where the first subparagraph applies, the period referred to in paragraph 1 shall be extended by the two periods referred to in that subparagraph. The applicant shall, if requested by the European Union reference laboratory, provide samples and analytical standards. The Authority shall communicate the draft conclusion to the applicant, the Member States and the Commission and give the applicant a possibility to submit comments within a period of two weeks. Comments and new information shall be considered by the Authority in cooperation with the rapporteur Member State and the co-rapporteur Member State. The Authority shall finalise the conclusion within 75 days from the expiry of the two-week period referred to in the first subparagraph. In cases where the Authority drafted the conclusion before the expiry of the five months period referred to in the first paragraph of this Article the remaining time may be added to the 75 days mentioned in the previous subparagraph. The Authority shall communicate its final conclusion to the applicant, the Member States and the Commission. The applicant shall be given the possibility to submit comments on the draft renewal report within a period of 14 days. An applicant may be replaced by another producer in respect of all of its rights and obligations under this Regulation by informing the rapporteur Member State, by a joint declaration made by both of them. In that case, both shall, at the same time, inform of the replacement the co-rapporteur Member State, the Commission, the other Member States, the Authority and any other applicants that have submitted an application for renewal for the same active substance. In case of simultaneous applications for renewal for more than one active substance, for which at least part of the risk assessment can be considered applicable to all of the active substance applications for renewal, fees shall be proportionate and applied taking into consideration that a common risk assessment might be performed. However, it shall continue to apply to the procedure for the renewal of the approval of the active substances:. The Annex to that Implementing Decision demarcates and lists certain areas of the Member States concerned in Parts I to IV thereof, differentiated by the level of risk based on the epidemiological situation as regards that disease. In September , a case of African swine fever in wild boar was observed in Germany in the state of Brandenburg of that federal Member State. In November , Germany informed the Commission of a new case of African swine fever in a wild boar in the state of Saxony of that federal Member State. Accordingly, these areas of Germany in the states of Brandenburg and Saxony of that federal Member State affected by these recent cases of African swine fever should now be listed in Parts I and II of that Annex. Following the recent cases of African swine fever in feral pigs in Germany and taking into account the current epidemiological situation in the Union, regionalisation in this Member State has been reassessed and updated. In addition, the risk management measures in place have also been reassessed and updated. These cases of African swine fever in feral pigs constitute an increased level of risk, which should be reflected in that Annex. Accordingly, these areas of Poland currently listed in Part I of that Annex, that are in close proximity to areas listed in Part II affected by these recent cases of African swine fever, should now be listed in Part II of that Annex instead of in Part I thereof. The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,. Avian influenza is an infectious viral disease in birds, including poultry. Infections with avian influenza viruses in domestic poultry cause two main forms of that disease that are distinguished by their virulence. The low pathogenic form generally only causes mild symptoms, while the highly pathogenic form results in very high mortality rates in most poultry species. The disease may have a severe impact on the profitability of poultry farming causing disturbance to trade within the Union and exports to third countries. Since , highly pathogenic avian influenza HPAI viruses of the H5 subtype have shown to be able to infect migratory birds, which can then spread these viruses over long distances during their autumn and spring migrations. The presence of HPAI viruses in wild birds poses a continuous threat for the direct and indirect introduction of these viruses into holdings where poultry or other captive birds are kept. In the event of an outbreak of HPAI, there is a risk that the disease agent may spread to other holdings where poultry or other captive birds are kept. That Directive provides for the establishment of protection and surveillance zones in the event of an outbreak of HPAI. This regionalisation is applied in particular to preserve the health status of birds in the remainder of the territory of the country by preventing the introduction of the pathogenic agent and ensuring the early detection of the disease. The Commission has examined those measures in collaboration with the United Kingdom, and it is satisfied that the borders of the protection and surveillance zones, established by the competent authority of the United Kingdom, are at a sufficient distance to the holdings where the outbreaks were confirmed. In order to prevent any unnecessary disturbance to trade within the Union and to avoid unjustified barriers to trade being imposed by third countries, it is necessary to rapidly describe the protection and surveillance zones established in relation to HPAI in the United Kingdom at Union level. United Kingdom. Those parts of the county of Cheshire ADNS code extending beyond the area described in the protection zone and within the circle of a radius of ten kilometres, centred on WGS84 dec. Those parts of the county of Herefordshire ADNS code extending beyond the area described in the protection zone and within the circle of a radius of ten kilometres, centred on WGS84 dec. Having regard to the Treaty on the Functioning of the European Union, and in particular Article thereof,. In line with Article 7 of the Treaty on the Functioning of the European Union 1 , the definition of health policy as well as the organisation and delivery of health measures remain a national competence. The number of SARS-CoV-2 infection continues to rise and is putting pressure on healthcare workers involved in sampling as well as laboratories performing the COVID tests, resulting in increasing turn-around times between the test request and result. Moreover, improved access to COVID test sites and services compared to earlier in when Europe experienced its first pandemic wave, has resulted in high peaks in testing demands, often exceeding available testing capacities. Scientific and technical developments continue to evolve, offering new insights on the characteristics of the virus and the possibilities for using different methodologies and approaches for COVID diagnosis. A new generation of faster and cheaper tests is increasingly available on the European market: the so-called rapid antigen tests, which detect the presence of viral proteins antigens , can be used to detect an ongoing infection. According to the Directive, for SARS-CoV-2 rapid antigen tests, the manufacturer must draw up a technical file which explicitly shows that the test is safe and performs as intended by the manufacturer, by demonstrating compliance with the requirements laid down in Annex I to the Directive. Following this, the manufacturer may issue an EU declaration of conformity and affix CE-marking to their device. Under the Regulation, rapid antigen tests will be subject to reinforced requirements on device performance and a thorough assessment by a notified body. The manufacturer must also state the levels of analytical performance of the device, which must correspond to the intended purpose. The information accompanying the device must take account of the training and knowledge of the potential users. The WHO published on 11 September interim guidance on the use of rapid antigen tests for COVID detection 9 , offering countries with advice on the potential role played by these tests and the need for careful test selection. As stressed by WHO, while the rapid antigen tests may offer helpful solutions for the diagnosis of SARS-CoV-2 infection in a range of settings and scenarios, their clinical performance is not yet optimal and caution should be exercised. The use of rapid antigen tests offers the potential for rapid identification of those individuals at greatest risk of spreading the infection, particularly in circumstances of high community transmission. This guidance provides the framework within which testing for SARS-CoV-2 critically contributes to generating reliable surveillance data, achieving control of transmission in the community, preventing transmission in high-risk settings, and limiting virus reintroduction in communities that have achieved sustained transmission control. Most of the currently available rapid antigen tests show a lower sensitivity compared to RT-PCR tests. The ECDC guidance 11 on the use of rapid antigen tests defines the suitability of various testing strategies in different epidemiological contexts, settings, and expected clinical performance, based on currently available evidence. Sensitivity of rapid antigen tests increases if they are applied to populations up to 5 days of symptom onset and tested in specimens with high viral load. However, rapid antigen tests can offer a significant advantage over RT-PCR tests in terms of simplicity of equipment needed, lower demands of highly skilled operators, price and timeliness of results, by providing health services with easy to use and rapid results which will also help to relieve the pressure on healthcare systems. For instance, when used in targeted population-wide testing approaches, the risk of not detecting all cases or risk of false negative results is counter-balanced by the timeliness of results and the possibility of recurred testing of initially negative individuals. The predictive value of a positive or negative test result depends on the test performance and infection prevalence in the population tested. Interpretation of the results of rapid antigen tests should therefore duly consider these elements. Regarding the possibility to use of antigen tests in asymptomatic persons, it should be noted that, until now, very limited data is available regarding the performance of rapid antigen tests in this context. The possibility to use rapid antigen tests for travellers might be further considered, taking into account the latest scientific and technological developments in light of the epidemiological situation. Its role is to reinforce the coordination and sharing of best practice and information on national preparedness and response planning. The use of rapid antigen tests has been discussed since early September Several Member States have started to use rapid antigen tests in practice and have included their use in their national COVID testing strategies. Additionally, the majority of Member States are currently carrying out validation studies or pilots to assess the clinical performance of rapid antigen tests in specific settings and for the diagnosis of SARS-CoV-2 infection among certain target populations. The Commission Recommendation on COVID testing, including the use of rapid antigen tests 12 of 28 October sets out guidance for countries regarding key elements to be considered for national, regional or local testing strategies. It provides recommendations focused on the scope of COVID testing strategies, groups to be prioritised, and specific situations to be considered, and addresses key points linked to testing capacities and resources. It also recommends that Member States should agree on criteria to be used for the selection of rapid antigen tests, particularly those related to their clinical performance such as sensitivity and specificity, as well as to reach agreement on the scenarios and settings during which rapid antigen tests are appropriate to be used, such as for example in circumstances of high community transmission. The Recommendation also included a commitment by the Commission to work with Member States towards creating a framework for evaluation, approval and mutual recognition of rapid tests, as well as for mutual recognition of test results, which this Recommendation contributes towards. Economic operators must comply with the requirements set out in the applicable EU law. By fulfilling these requirements and affixing the CE marking to a product, a manufacturer declares that the product meets all the legal requirements for CE marking and that its product can be sold throughout the EEA. Member States have the possibility to restrict the availability of certain devices if they believe this is in the interest of protection of health and safety or in the interest of public health The choice of tests at national level depends on the availability of the tests as well as national testing strategies in place, including, for example, the purposes for which the tests are intended to be used, in what combinations, and the accepted levels of performance, taking into consideration the epidemiological and clinical situation of the concerned Member State, region, particular health institution or patient group. Cooperation at EU level in assessing the evidence gathered from the use of these tests in clinical practice, including through the Joint Action EUnetHTA, can provide important benefit to inform national strategies. Effective testing plays a key role in the smooth functioning of the Internal Market as it allows for targeted isolation or quarantine measures. Member States health services should mutually recognise results of rapid antigen tests following the guidance set out in this Recommendation. The implementation of an EU HTA framework would provide an important instrument to work jointly, pool resources, share expertise and provide evidence necessary to inform decisions including on the use of antigen tests. Furthermore, in order to provide additional support to Member States for introducing the use of rapid antigen tests, the Commission has identified EUR million from the European Support Instrument ESI for the purchase and distribution of rapid antigen tests to Member States. In addition, the Commission has launched a joint procurement with Member States to facilitate the fair and equitable access to rapid antigen tests. It may be updated in the light of new scientific evidence, the latest technological developments and evolving epidemiological situation,. COVID testing strategies and objectives. Published on Article 3 Entry into force and application This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Done at Brussels, 14 July Article 2 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Done at Brussels, 16 November Article 3 Entry into force This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. Done at Brussels, 20 November If yes, body authorised to issue it No Proof of origin for release into free circulation Yes. Article 2 Scope This Regulation shall apply to the renewal of the approval of active substances whose approval period ends on or after 27 March Article 3 Notification of intended studies and advice on intended studies 1. Article 4 General pre-submission advice 1. Article 5 Submission of the application for renewal 1. Article 6 Content of the application for renewal 1. Article 7 Format and software for the submission of the application for renewal 1. Article 8 Admissibility of the application for renewal 1. Article 12 Comments on the draft renewal assessment report 1. Article 13 Conclusion by the Authority 1. Article 14 Renewal report and renewal Regulation 1. Article 15 Replacement of the applicant An applicant may be replaced by another producer in respect of all of its rights and obligations under this Regulation by informing the rapporteur Member State, by a joint declaration made by both of them. Article 16 Fees and charges 1. Article 18 Entry into force and application This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 27 March Article 2 This Decision is addressed to the Member States. Estonia The following areas in Estonia: — Hiiu maakond. Bulgaria The following areas in Bulgaria: — the whole region of Haskovo, — the whole region of Yambol, — the whole region of Stara Zagora, — the whole region of Pernik, — the whole region of Kyustendil, — the whole region of Plovdiv, — the whole region of Pazardzhik, — the whole region of Smolyan, — the whole region of Burgas excluding the areas in Part III. Article 3 This Decision shall apply until 31 December A critical point, often neglected, is the collection of the sample. Protocols for an efficient sample acquisition and handing should also be available. In such situations, the risk of not detecting all cases or the risk of false negative results is counter-balanced by the timeliness of results and the possibility of recurred testing of initially negative individuals. A confirmatory test will allow further informing the diagnosis, as stated in this Recommendation. The risk related to missing positive cases and the risk related to implementing isolation and quarantine measures due to falsely identified positive cases need to be assessed in such situations. This could be addressed by a confirmatory test. If a rapid antigen test is used in a population with low infection prevalence, positive results should be confirmed either by RT-PCR or by a repeated rapid antigen test. In both situations, the use and choice of the confirmatory test depends on the tolerability of the risk associated with missing positive cases or with detecting falsely positive cases. If there are shortages of RT-PCR assays or if the result turn-around-time of these is beyond 24 hours, the choice of a rapid antigen tests can be justified, depending on the intended use and the tolerability of the risk associated with its performance limitations. Manufacturer instructions for sample collection, safe handling, use and disposal need to be strictly followed, including specimen type and intended use. Appropriate biosafety measures must be in place when sampling, handling and processing specimens. Member States need to ensure sufficient capacities and resources for sampling, testing and reporting. To ensure these capacities, it might be necessary to train additional test operators other than healthcare personnel. Accreditation also ensures that these laboratories are controlled on a regular basis and comply with the necessary quality and competence requirements. Testing strategies should consider continuously the new information coming from these validation studies and be adapted accordingly, if necessary. Results performed with tests that have been validated at national level by one Member State and that meet the criteria of sensitivity and specificity of this Recommendation, should be recognised by other Member States. Done at Brussels, 18 November Official Journal of the European Union. Annex I is amended as follows: a. Methyl 2-methylphenyloxiranecarboxylate BMK methyl glycidate. Methyl alpha -phenylacetoacetate MAPA. New quantity. In accordance with Articles 6, 7 and 8 of this Regulation. EUR 0. EUR 75 per kg. In accordance with Article 13 of this Regulation. Rucavas novada Dunikas pagasts. Gemeinde Byhleguhre-Byhlen,. Gemeinde Neu Zauche,. Gemeinde Spreewaldheide,. Gemeinde Straupitz mit der Gemarkung Straupitz,. Gemeinde Gusow-Platkow,. Gemeinde Lietzen,. Gemeinde Falkenhagen Mark ,. Gemeinde Zeschdorf,. Gemeinde Treplin,. Gemeinde Wendisch Rietz,. Gemeinde Reichenwalde,. Gemeinde Diensdorf-Radlow,. Gemeinde Bad Saarow,. Gemeinde Langewahl,. Gemeinde Briesen Mark ,. Gemeinde Jacobsdorf,. Gemeinde Peitz,. Gemeinde Tauer,. Gemeinde Turnow-Preilack,. Gemeinde Drachhausen,. Gemeinde Schmogrow-Fehrow,. Gemeinde Drehnow,. Gemeinde Guben mit der Gemarkung Schlagsdorf,. Gemeinde Bad Muskau,. Aizkraukles novads,. Jaunjelgavas novads,. Jaunpiebalgas novads,. Vecpiebalgas novads,. Locality Romuli. Gemeinde Mixdorf,. Gemeinde Schlaubetal,. Gemeinde Neuzelle,. Gemeinde Lawitz,. Gemeinde Vogelsang,. Gemeinde Ziltendorf,. Gemeinde Wiesenau,. Gemeinde Friedland,. Gemeinde Brieskow-Finkenheerd,. Gemeinde Ragow-Merz,. Gemeinde Beeskow,. Landkreis Dahme-Spreewald: Gemeinde Jamlitz,. Gemeinde Lieberose,. Gemeinde Bleyen-Genschmar,. Gemeinde Golzow,. Gemeinde Alt Tucheband,. Gemeinde Reitwein,. Gemeinde Podelzig,. Gemeinde Letschin mit der Gemarkung Sophienthal,. Area comprising:. From From 9. It recommends Member States to conduct rapid antigen tests in addition to RT-PCR tests in clearly defined settings where the deployment of antigen tests is appropriate, and with the aim to contain the spread of the coronavirus, to detect SARS-CoV-2 infections and to limit isolation and quarantine measures. This Recommendation also contributes to ensuring the free movement of persons and the smooth functioning of the internal market, in times of limited testing capacities. In particular, the present Recommendation focuses on criteria to be used for the selection of rapid antigen tests, the settings during which rapid antigen tests are appropriate to be used, test operators, and validation and mutual recognition of rapid antigen tests and their results. Member States should aim to use rapid antigen tests with acceptable test performance, i. Rapid antigen tests should be used within five days after the onset of symptoms or within seven days after exposure to a confirmed COVID case. Before rapid antigen tests are adopted for use, Member States should ensure that such tests carry a CE-marking 16 and, before they are introduced into clinical practice, that those tests have been validated, as described in this Recommendation, against the standard RT-PCR tests and within the target population and setting intended for use. When the availability of RT-PCR tests is temporarily limited, the use of rapid antigen tests can be considered for individuals with COVID compatible symptoms in areas where the proportion of test positivity is high or very high, e. In order to mitigate the impact of COVID in healthcare and social-care settings, rapid antigen tests use should be considered at admission to healthcare facilities, as well as for triage of symptomatic patients or residents up to 5 days since symptom onset , including for assigning patients to isolation facilities. Rapid antigen tests use should also be considered for a targeted population-wide testing approach, e. In low prevalence situations, the use of rapid antigen tests should be focused on settings and situations where a fast identification of infected individuals is supporting the management of outbreaks and the regular monitoring of high risk groups, such as medical personnel or other long-term care facilities. If a rapid antigen test is used in a population with high infection prevalence, negative results should be confirmed either by RT-PCR or by a repeated rapid antigen test. In addition to the considerations above, the choice of a given diagnostic test depends on existing testing capacities. Trained healthcare and laboratory staff are needed to carry out sampling, testing, test analysis and reporting of test results to clinical staff and public health authorities at local, regional, national and international level. Capacity for confirmatory RT-PCR testing needs to be in place when applying rapid antigen tests as appropriate. Member States should use technical guidance developed by ECDC 17 on the use of rapid antigen tests for COVID, particularly as regards the clinical validation of these tests, to ensure reliability and comparability of results, when performing independent validations of rapid antigen tests. Member States should share with ECDC and the Commission, as soon as they become available, their validation results and corresponding testing strategies by intended use, with the aim of aligning them as much as possible with other Member States, and share any other information on results of validation studies carried out on rapid antigen tests independently of studies conducted by test developers and manufacturers. ECDC, in cooperation with Commission services and Member States, will prioritise and coordinate the validation of existing and upcoming types of rapid tests e. The Commission will facilitate joint work and exchange of information on nationally conducted health technology assessments on rapid antigen tests between Member States.

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