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Sample translations submitted: 1
English to Chinese: Instructions on Medicine General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English (t)he holder of the authorisation will inform the Spanish Agency of Medicine and Healthcare Products of the date foreseen for the manufacture of the first lot for sale, as well as for placing the authorised medication on the market, which may not in any case exceed one year from the date of the present authorisation, as set out in section 1 of article 35 of Royal Decree 767/1993.
The authorisation of this medication is valid for five years (unless the authorisation is subject to special conditions establishing an earlier deadline, as set out, in that case, in Appendix II of the present ruling) from the date of issue. It may be renewed, after the technical documentation of the registration is updated and the corresponding procedures for this purpose have been followed.
This ruling is the end of the executive authority procedure, but it may be challenged by filing an annulment appeal before the Director of the Spanish Agency of Medicine and Healthcare Products within the time limit of one month, as is set out in article 116 of Law 30/1992, dated the 26th November, regarding the Legal Ruling of Public Bodies and Common Executive Authority Procedure, or by filing a Judicial Complaint against an administrative decision before the Higher Court of Justice of the Autonomous Government of Madrid, within the time limit of two months counting from the day following the reception of the present notification, as is set out in the Law Regulating the Jurisdiction of Appeals against Administrative Acts dated the 13th July of 1998, without prejudice to any other appeal that may be filed.
Translation - Chinese 药品许可证持有人应通知西班牙药品保健品署其首批上市产品的预期生产时间， 以及市场投放。根据西班牙1993年版皇家法典第35章第一节之规定，具体时间不得超出自许可日起一年。
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