FDA对于药品标签上NDC的要求
注册申报
FDA的法规上对于NDC申请的规定为:每个从事manufacturing, repacking, relabeling, or private label distribution of a drug subject必须申请NDC labeler code。是否可以理解为标签上印制的NDC号只可能是以上这种身份的公司/个人申请的号码?如果分销商不是private label distributor, 仅是作为MAH的销售代理公司,可以申请到NDC号吗?
2024-02-18 14:27 Wendy     
1个回答

不属于这几个角色的话应该就不需要NDC。

因为你没说你提到的经销商是否会在产品上使用它的标签logo等,所以无法直接判断它是否属于这几个角色。21 CFR 207.1对于repacking, relabeling, or private label distribution的行为和角色均有具体定义,你可以再详细对照一下下面看看你说的代理是否属于 repacking, relabeling, 或private label distribution的范畴。

  • Private label distribution  means commercial distribution of a drug under the label or trade name of a person who did not manufacture, repack, relabel, or salvage that drug.
    Private label distributor   means, with respect to a particular drug, a person who did not manufacture, repack, relabel, or salvage the drug but under whose label or trade name the drug is commercially distributed.
  • Relabel  means to change the existing label or labels on a drug or drug package, or change or alter the existing labeling for a drug or drug package, without repacking the drug or drug package. This term does not include the addition or modification of information affixed solely for purposes of delivery to a customer, customer identification, and/or inventory management.
    Relabeler means a person who owns or operates an establishment that relabels a drug. When not modified by “domestic” or “foreign,” the term includes both domestic relabelers and foreign relabelers.
  • Repack or repackage means the act of taking a finished drug product or unfinished drug from the container in which it was placed in commercial distribution and placing it into a different container without manipulating, changing, or affecting the composition or formulation of the drug.
    Repacker means a person who owns or operates an establishment that repacks a drug or drug package. When not modified by “domestic” or “foreign,” the term includes both domestic repackers and foreign repackers.
2024-02-20 22:01 白bai     
Wendy 2024-02-22 14:58

谢谢您的回复。目前标签上的logo以及商品名均是manufacturer的,委托代理销售的分销公司只是负责商业环节的纯销售工作,如果按照Private label distributor的定义,应不属于该身份。

想和您再确认一个情况:如果使用了private label distribution, 则这个分销公司拥有该label或者说该药品品牌,那如果在以后想变更这个分销公司,是否这款药品的label以及品牌都需要变更?

白bai 2024-02-28 21:00

如你标签上使用了分销公司的 NDC 号及 logo ,后来变更了分销公司(不使用他们的 NDC 号和 logo 了),那标签是需要变更的。然后你 labeler 也是要变掉的。

Wendy 回复 白bai 2024-03-04 15:30

那么商品名需要也变更吗?是否允许标签上的商品名不变,只变更分销公司的NDC号和公司的LOGO?