事前審査・届出
スイス ／ Swissmedic
スイスには全面的な事前審査制度は無く、事前認可が必要なのは、医薬品情報に濫用または依存の可能性が記載されている鎮痛薬・睡眠薬・鎮静薬・下剤・食欲抑制薬について第15条aおよびcの形態で行う一般向け広告に限られ、加えてスイスメディックは、広告規定に重大または反復して違反した承認取得者に対し、相当な期間すべての広告案を事前に提出させることができる。
Switzerland has no across-the-board pre-vetting scheme: prior authorisation by Swissmedic is required only for advertising to the public under Art. 15(a) and (c) for analgesics, sleeping aids, sedatives, laxatives and anorectics where the medicinal product information mentions a potential for abuse or dependence, and, in addition, Swissmedic may require a marketing authorisation holder that has seriously or repeatedly infringed the advertising provisions to submit all planned advertising for review and approval before publication for an appropriate period.
注記
Read in German on Fedlex, and the scope was checked against the ordinance text rather than assumed. Art. 23 Abs. 1 is limited in three ways at once: to Publikumswerbung (advertising to the public, not professional advertising), to the forms in Art. 15 lit. a (advertisements in newspapers, journals and books, brochures, posters, circulars etc.) and lit. c (electronic media such as image, sound and data carriers and application software), and to five named product groups, and it bites only where the approved product information mentions a potential for misuse or dependence. Art. 23 Abs. 2 is a sanction-triggered pre-clearance imposed on an individual company. Art. 25 separately requires each MAH to designate a person responsible for advertising, who must satisfy herself that the advertising complies, ensure Swissmedic's orders are followed immediately and in full, supply Swissmedic with any requested documents, and keep a copy of every advertisement disseminated for six months after its last intended use together with a record of all recipients, the manner of dissemination and the date of first dissemination.
Read in German on Fedlex, and the scope was checked against the ordinance text rather than assumed. Art. 23 Abs. 1 is limited in three ways at once: to Publikumswerbung (advertising to the public, not professional advertising), to the forms in Art. 15 lit. a (advertisements in newspapers, journals and books, brochures, posters, circulars etc.) and lit. c (electronic media such as image, sound and data carriers and application software), and to five named product groups, and it bites only where the approved product information mentions a potential for misuse or dependence. Art. 23 Abs. 2 is a sanction-triggered pre-clearance imposed on an individual company. Art. 25 separately requires each MAH to designate a person responsible for advertising, who must satisfy herself that the advertising complies, ensure Swissmedic's orders are followed immediately and in full, supply Swissmedic with any requested documents, and keep a copy of every advertisement disseminated for six months after its last intended use together with a record of all recipients, the manner of dissemination and the date of first dissemination.