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21.06.2017

Swissmedic specifies Requirements forRPs

瑞士药监发布RP要求

Inthe Swissmedic Journal 05/2017 - Swissmedic's official publication paper- theSwiss Agency for Therapeutic Products released specifications about the SwissResponsible Person'sindependenceand obligation of presence (the Responsible Person - RP -or "Fachtechnisch verantwortliche" Person (FVP) is equivalent tothe Qualified Person in the EU). The revised requirements have also beenpublished in the TechnicalInterpretation I-SMI.TI.17 which is also available on theSwissmedic website.

在2017年5月瑞士药监杂志（瑞士药监官方出版物）上，瑞士药监发布了瑞士药品负责人独立性和义务规范（负责人---RP，或称为“Fachtechnischverantwortliche”人（FVP）等同于EU的授权人）。修订后的要求也发布在技术说明（TechnicalInterpretation I-SMI.TI.17）上，在瑞士药监的官网上也可以找到。

Accordingto the Swiss legislation, the Responsible Person (RP) has to have thenecessary authorisation to execute his/her responsibility - in particularwith regard to the market release (Medicinal Products Licensing Ordinance, art.5, paragraph 1). This implies a certain independence, also from the uppermanagement (paragraph 2). Details regarding the scope of this independence havenow been provided:

根据瑞士法律，RP必须有足够的授权为履行其职责---尤其是上市放行（药品许可法，第5章第1段）。这意味着要具有一定独立性，独立于更高管理层（第2段）。关于此独立性范围的具体内容现在发布如下：

Accordingto the Swissmedic, independence is no longer guaranteed in case of a personalunion of RP as CEO, principal shareholder, or chairman of the board. As a result, this constellation is nolonger acceptable for Swissmedic.

根据瑞士药监说法，如果一个RP同时是CEO、大股东或董事会主席，那么将无法再确保其独立性。因此，这些人员将不再被瑞士药监接受作为RP。

Thenecessary technical supervision of the RP relies on his/her regular presence atthe facilities. Nevertheless, according to art. 5 paragraph 6 of the MedicinalProducts Licensing Ordinance it is basically possible to carry out the functionon a part-time basis.Now, the conditions for that have also been specified:

RP所需的技术监管有赖于其经常出现的生产现场。但是，根据药品许可法第5章第6段，可以兼职实施这些职责。现在这种情况也进行了说明：

Thedirect supervision by a part-time RP is understood as the supervision of atleast all the critical steps/operations with regard to the company's facilitiesas well as the guarantee of compliance with the legal provisions. Thisimplies that the minimum hours of presence have to be defined in acontract. The considerations forming the basis for the specified minimum hoursof presence should be stated in writing and the minimum hours of presence"should normally not be below 10% of a full time position".

兼职RP的直接监管被认为是至少对公司生产场所的所有关键步骤/操作所进行监管，确保其符合法律条款的要求。这意味着在合同时必须要说明在现场的最少时长。这种考量成为书面写明出现场时间的最少时长依据，最少时长“应一般不少于全职岗位的10%”。

Thenew requirements will enter into force as of 1st July 2017 without anytransition period.

新要求将自2017年7月开始实施，无过渡时间。