EU common standards medical equipment.\u00a0 EU directive provides for harmonisation of safety in relation to active inplantable medical devices. They may be placed on the market provided the devices meet essential criteria as set out in the directive and lawfully bear the CE Mark.\u00a0 They must be permitted on to the market in any \u00a0state.<\/p>\n
States are to publish standards implementing the harmonised standards., equipment and devices complying with the harmonised standards assumed to meet the essential safety requirements in the directive.\u00a0 Special measures may be taken when devices or national standards do not meet the essential health and safety requirements.\u00a0 There is provision for consultation with a standing committee and provisions to withdraw the product from the market or in the case of a standard, revoke it.<\/p>\n
A manufacturer must notify the competent authorities of any incident causing death or damage to the health of a patient.\u00a0 It must apply certain vigilance procedures and systems.<\/p>\n
Devices must be subject to a conformity assessment procedure.\u00a0 States must designate authorities responsible for the procedure. The directive provides for the essential safety requirements, CE-type examination, verification, declaration of conformity to type, statements for devices intended for special services, clinical evaluation, minimum criteria and designating inspection bodies,<\/p>\n
EU \u00a0regulation provides a procedure allowing businesses to manufacture generic pharmaceutical products for export by which they may apply to their national authorities for the grant of a compulsory license from a patent holder with an exclusive right to the product in question.\u00a0 A pharmaceutical product is any product in the pharmaceutical sector including medical products, under the EU Code for medicinal products for human use.<\/p>\n
Compulsory licenses are granted where the products are intended for export to eligible importing countries with public health issues and problems.\u00a0 Thecountries concerned are the least developed countries, WTO members other than LDCs who have notified the council for trade-related aspects of intellectual property rights of their intention to use the system as importers and non-WTO members listed as low income countries by the OECD who have notified the Commission of their intention to use the system as importers.<\/p>\n
The applicant must prove he has received a request from an importing country or its authorised representative or a health organisation, United Nations body or other acting with the authority on of one of the importing countries.<\/p>\n
The authority must notify the rights holder without delay of the application.\u00a0 Authorities must vouch that the relevant requirements have been complied with.\u00a0 The applicant must show that it has endeavoured to obtain authorisation from the rights holders and that this has not been successful within a period of 30 days.\u00a0 This provision does not apply in the case of emergency or in cases of public non-commercial use.The authority must refuse the license if the conditions are not met.<\/p>\n
The license is limited to the quantities required by the importing country.\u00a0 They may not be sold or marketed in any other third country.\u00a0 That is an exception for export to partners regional trade agreement countries with the same health issues and qualifications.<\/p>\n
Products manufactured under license must be clearly marked by a special label distinguishing them from manufacturers by the rights holders.\u00a0 This is provided that it is possible and does not have a significant impact on the price.<\/p>\n
f the products are patented in the importing country they may be exported only if those countries have issued a compulsory license for the importation, sale and distribution of their products.<\/p>\n
The license holder must make a suitable payment to the rights holder.\u00a0 This is calculated by the competent authority on the basis of the economic value of the authorised use under the license and non-commercial factors.\u00a0 In the case of an emergency or public non-commercial use payment is fixed at a maximum of 4% of the price paid by the importing country.<\/p>\n
There are measures to ensure that medicines are not re-imported into the EU.\u00a0 Imports are banned and customs authorities must take measures against re-imported products.<\/p>\n
A patent holder may appeal the decision and use national rules relating to disputes regarding compliance with licence conditions.\u00a0 A licence may be terminated if the holder fails to comply with conditions.\u00a0 After termination he must arrange within a reasonable time for products in his possession and control to be dispatched at his expense to countries that need \u00a0them.<\/p>\n
Applicants for a license must make use of the EU procedure for scientific opinion or other procedures to ensure the safety of the product.<\/p>\n
2003 regulation creates a system enabling pharmaceutical producers to sell to developing countries essential medicines at reduced prices while ensuring they do not find their way back into the EU.\u00a0 The purpose is to secure essential medicines for developing countries seeking to fight major communicable diseases.<\/p>\n
Manufacturers and exporters must submit applications to the Commission for the products to be qualified as tiered price products.\u00a0 The application must specify the name and composition, proposed price and the country of destination.\u00a0 If the commission assisted by committees or representatives decides that the application fulfils the criteria in the directive, the product is added to Annex 1 and the applicant is informed.<\/p>\n
In setting tiered prices the manufacturer, exporter may charge direct \u00a0cost plus 15% or 25% of the average price charged in OECD countries.It is illegal to import tiered price products into the EU for the purposes of free circulation.<\/p>\n\n
EU common standards medical equipment.\u00a0 EU directive provides for harmonisation of safety in relation to active inplantable medical devices. They may be placed on the market provided the devices meet essential criteria as set out in the directive and lawfully bear the CE Mark.\u00a0 They must be permitted on to the market in any \u00a0state. […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"categories":[210],"tags":[],"_links":{"self":[{"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts\/13477"}],"collection":[{"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/comments?post=13477"}],"version-history":[{"count":3,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts\/13477\/revisions"}],"predecessor-version":[{"id":18605,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts\/13477\/revisions\/18605"}],"wp:attachment":[{"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/media?parent=13477"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/categories?post=13477"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/tags?post=13477"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}