Country Requirements for Employer Notification or Approval
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- Buddy McDowell
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1 Algeria Australia Austria Belgium Brazil For Product Training Meetings and Sponsorships to Third-Party Educational Events involving significant travel, government employed HCPs must seek approval from their employing institution or the MoH. (2) traveling overseas*. Sponsorships to Third-Party Educational Events are not allowed in ANZ. *Overseas: This includes all travel outside of the HCP s home country. This includes travel between Australia and New Zealand i.e. if a HCP from New Zealand travels to a Product Training Meeting in Australia then it is classified as overseas. For Product Training Meetings or Sponsorships to Third-Party Educational Events, use the employer approval template to gain approval from the HCP's employer before receipt of any hospitality unless competent bodies or other designated competent authorities (e.g. Hospital Administrative Department; Legal Department) have confirmed in writing that such approval is not deemed necessary. This rule applies to government or privately employed HCPs. Sponsorship (direct or indirect) of an HCP to attend a Product Training Meeting or third party event that includes one night (either because the HCP must arrive the day before or because this is at least a 2 days long event): prior visa (=authorization) from Mdeon is required. The visa request must be received by Mdeon at least 15 working days preceding the commencing date of the meeting (or 6 working days preceding the commencing date of the meeting if this meeting gathers a maximum of 15 HCPs, faculties and attendees included). In case of substantial modification of the initial approval request, a new approval request can be submitted at least 6 working days before the beginning date of the event. In case of refusal from Mdeon, a new approval request can be submitted to Mdeon, at least 6 working days before the beginning date of the event. For Sponsorships to Third-Party Educational Events, employer notification is required, in addition to Mdeon visa or when Mdeon visa is not required. For Product Training Meetings with no reimbursed travel employer notification is not required. For Product Training Meetings with significant or limited travel, employer notification is required, in addition to Mdeon visa or when Mdeon visa is not required. Use the employer notification template. For all Sponsorships to Third-Party Educational Events, use the employer notification template, except as noted below. For Product Training Meetings where ANVISA Officials are going to be sponsored: The Rules of Conduct of the public officials of ANVISA require that notification be provided to ANVISA three months before a S&N sponsored meeting, including the place, date and type of participants. 1
2 Bulgaria Canada China Colombia Czech Republic Denmark Dominican Republic Egypt Finland France For Product Training Meetings or Sponsorships to Third-Party Educational Events, use the employer notification template, except as noted below. For Sponsorships to Third-Party Educational Events, use the employer notification template. (2) traveling outside his home country or traveling more than 4-hours by air or rail, one For oversea trip (plus the trip to Hong Kong, Taiwan, Macao) related to Sponsorships to Third-Party Educational Events or Product Training Meetings, use the employer approval template to request the chop approval of the Employers of HCPs. For domestic trip, employer notification is the responsibility of HCP according to the Letter to HCP signed by HCP. For Product Training Meetings or Sponsorships to Third-Party Educational Events, with limited travel or significant travel, use the employer notification template to notify the HCP s employing institution or the MoH, except as noted below. For HCPs fully or partially employed by the government, use the employer notification template for Product Training Meetings with no reimbursed travel where a meal is being provided. For HCPs who are registered to a Board (Doctors, Nurses, Pharmacists, Physiotherapists and Midwives), healthcare students or HCPs who work in the Army: - Registration, travel, meals and accommodation costs must be the subject of a hospitality agreement with the HCP or healthcare student and notified in advance to the French competent Board (for HCPs not working in Army and health students), as CNOM for Doctors, (Doctors, Pharmacists or Nurses Physiotherapists or Midwives) or to the Army. Notification must be received by these 2
3 Germany Greece Hong Kong Hungary India Indonesia Iran Ireland Israel Italy Boards or Army at least 30 calendar days before the beginning date of the event. For HCPs who are not registered to a Board or do not work in the Army, use the employer notification template For Product Training Meetings or Sponsorships to Third-Party Educational Events (for HCPs employed by a government institution or not) For Product Training Meetings or Sponsorships to Third-Party Educational Events, use the employer approval template. For Product Training Meetings or Sponsorships to Third-Party Educational Events, use the employer notification template, except as noted below. For Product Training Meetings or Sponsorships to Third-Party Educational Events, use the employer approval template to introduce the events, and request employer (Gov. Owned Hospital) to select their HCPs to attend the events. For Sponsorships to Third-Party Educational Events (faculty only), use the employer notification template, except as noted below. For Product Training Meetings or Sponsorships to Third-Party Educational Events (faculty only), use the employer approval template if the HCP is (1) fully or partially employed by the government and (2) traveling outside his home country or traveling more than 4-hours by air or rail, one For Sponsorships to Third-Party Educational Events and Product Training Meetings with Limited Travel, use the employer notification template if the HCP is NOT employed by the government. If the HCP is fully or partially employed by the government, use the employer approval template. For Sponsorships to Third-Party Educational Events and Product Training Meetings with Significant Travel, use the employer approval template for all HCPs. For Product Training Meetings, use the employer notification template. For Sponsorships to Third-Party Educational Events, use employer approval template. For Product Training Meetings or Sponsorships to Third-Party Educational Events, invitations to participate in meetings must be sent to the HCP s employer, who will select the individual HCPs who may participate. For Product Training Meetings or Sponsorships to Third-Party Educational Events (click here for templates): In all cases, prior to sending the notification/approval letter, the HCP must complete a Liberatoria, where the HCP declares her/his employment status: 3
4 Jamaica Japan Korea Latvia Lebanon Lithuania Malaysia Mexico Morocco Netherlands o MOD011Q22: HCP as attendee o MOD012Q22: HCP as faculty with no compensation o MOD013Q22: HCP as faculty with compensation Depending on the HCP employment status declared in the Liberatoria, one of following employer notification/approval letters must be sent: o Use Lettera A: HCP as attendee out of working time (notification) o Use Lettera B: HCP as attendee on working time (approval) o Use Lettera C: HCP as faculty with compensation (affirmative approval) o Use Lettera D: HCP as faculty with compensation (approval) Exception: University professors may not need employer approval if this foreseen by their regulation. Pharma code: non-speakers can t be invited to third party meetings more than twice a year. For Sponsorships to Third-Party Educational Events, use the employer notification template. (2) traveling outside his home country or traveling more than 4-hours by air or rail, one For Product Training Meetings, use the employer notification for public HCPs, regardless of meeting type or travel requirements. Sponsorships to Third-Party Educational Events are not allowed in Japan. For Product Training Meetings, in light of the approval and reporting requirements to the KMDIA, no additional employer notifications or approvals apply. Sponsorships to Third-Party Educational Events are not allowed in South Korea. Sponsors of meetings must keep sponsorship records (information about recipients of funding, types of funding and value) and submit annual reports to the State Tax Inspectorate. For public employees, invitations to meetings and third party educational conferences should be sent through the individual s employer. For Sponsorships to Third-Party Educational Events, Product-related Company Meetings (Product Training Meetings) and accredited Company Meetings (meeting accredited by a recognized professional body): A written document between S&N and the sponsored HCP 4
5 must state the expenses to be paid/reimbursed to the HCP in the course of the sponsorship. This document must be communicated in advance to the HCP s employer/institution. New Zealand (2) traveling overseas*. Sponsorships to Third-Party Educational Events are not allowed in ANZ. *Overseas: This includes all travel outside of the HCP s home country. This includes travel between Australia and New Zealand i.e. if a HCP from New Zealand travels to a Product Training Meeting in Australia then it is classified as overseas. Norway Philippines Poland For all Product Training Meetings and Sponsorships to Third-Party Educational Events, use the employer notification template. Portugal Puerto Rico For Product Training Meetings, use the employer approval template if the HCP is (1) fully or partially employed by the government and (2) traveling outside his home country or traveling more than 2-hours by air or rail, one Otherwise, employer notification or approval is not required. Sponsorships to Third-Party Educational Events are not allowed in Puerto Rico. Romania Russia Product Training Meetings with reimbursed travel and Sponsorships to Third-Party Educational Events are prohibited in Russia. Only Product Training Meetings with no reimbursed travel are allowed in Russia. o Use the HCP invitation template to invite the Russian HCP to a Product Training Meeting. o There are no employer notification or approval requirements for Russia for Product Training Meetings with no reimbursed travel. Saudi Arabia A female HCP may travel to a meeting alone with a letter of consent from her husband or male relative if unmarried, or if accompanied by her husband or guardian. In the latter case, it is permissible to pay for the husband or guardian s reasonable expenses. Singapore Slovakia 5
6 South Africa Spain Sweden Switzerland Syria Taiwan Thailand Tunisia Turkey Ukraine United Arab Emirates For Product Training Meetings and Sponsorships to Third-Party Educational Events, use the employer notification template. For Product Training Meetings or Sponsorships to Third-Party Educational Events, use the employer approval template for all HCPs, regardless of meeting type, travel requirements or how employs the HCP (public or private employer). Invitations should be addressed to the HCP s employer For Sponsorships to Third-Party Educational Events, use the employer approval template if the HCP is fully or partially employed by the government. For HCPs not employed by the government, use the employer notification template if the Sponsorship involves Significant Travel. For Product Training Meetings with Limited Travel or Significant Travel, use the employer approval template if the HCP is (1) a nurse, or (2) fully or partially employed by the government. For other HCPs not employed by the government, use the employer notification template for Product Training Meetings with Significant Travel only. For Product Training Meetings or Sponsorships to Third-Party Educational Events, use the employer notification template, except as noted below. (2) traveling outside his home country or traveling more than 4-hours by air or rail, one 6
7 United Kingdom United States Venezuela Vietnam For nurses, pharmacists and certain medical technicians, use employer approval template for Product Training Meetings or Sponsorships to Third-Party Educational Events with Limited Travel or Significant Travel. For Product Training Meetings, use the employer notification template. For Sponsorships to Third-Party Educational Events, use employer approval template. For Product Training Meetings with government-employed HCPs: use employer approval template. For non-government employed HCPs, employer notification or approval is not required. Sponsorships to Third-Party Educational Events are not allowed in the US. For Product Training Meetings or Sponsorships to Third-Party Educational Events, use the employer approval if the HCP is (1) fully or partially employed by the government and (2) traveling outside his home country or traveling more than 4-hours by air or rail, one way, inclusive of all travel segments. 7
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