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Note added at 1 hr (2006-10-22 11:10:08 GMT)
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you r right 《医疗机构制备正电子类放射性药品质量管理规范》=GMP
But：
Apllication for approval of new drug
Submission data for certification to manufacture a new drug

应该说这个原文写得不够清楚，甚至有歧异，在无从考证的情况下，只有适当理解句子的意思了。
我的理解是：根据《医疗机构制备正电子类放射性药品质量管理规范》，认证规定的申报资料应有目录，用A4幅面纸打印(左边距不小于3cm,页码标在右下角)。
这样句子就好理解一些了，即：经过（或需要）认证的规定的申报资料应该有目录。
英语可以这样说：there should be a list of required application documents that shall be certified.
上述仅供参考，所给建议是在作者真实意图无从查考的情况下退而求其次的办法，并不一定正确。

My suggestion: Specified application and support documents (required) for certification in accordance with 《医疗机构制备正电子类放射性药品质量管理规范》

I believe you are translating this official document issued by 国家食品药品监督管理局 and 中华人民共和国卫生部 as shown at http://www.jincao.com/fa/law10.125.htm
If so, the “认证规定的申报资料” refers to those specified in 附件8 of this document.

请参考 http://www.pd.dgs.ca.gov/smbus/certapps.htm

“The certification application process requires you to complete and submit a 2-page application (with an original signature) along with the required support documents as specified in the "Required Support Documents" section of the certification application and as described below.”

Required declaring material (data) for certification purpose

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Note added at 12 hrs (2006-10-22 22:24:49 GMT)
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申报资料: the submission of information, the submission documentation, the submission of the documents required/the required documents, submission documents, the submission...:

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Note added at 12 hrs (2006-10-22 22:32:08 GMT)
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'医疗机构制备正电子类放射性药品质量管理规范》认证规定' 是一个词 ?


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Note added at 2 days11 hrs (2006-10-24 21:47:12 GMT) Post-grading
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制备 = to prepare, make up, (prescribe) medicines (what pharmacists do):

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Note added at 2 days12 hrs (2006-10-24 22:09:13 GMT) Post-grading
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制备品
制备方法
preparation n.准备，预备；制备

Shang's
医疗机构制备正电子类放射性药品质量管理规范 = Good Supply Practice for Medical Institutes to Prepare PET (Positron Emission Tomography) Pharmaceutical Products

注意题目里的: 制备XXX药品 = the making up of/ the preparation of XXX medicinal products, medicines? :
制备正电子类放射性药品

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Note added at 2 days12 hrs (2006-10-24 22:12:19 GMT) Post-grading
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制备品 = made-up (or sometimes proprietory?) medicines/medicaments/medicinal products