{"id":23000612,"date":"2026-02-04T16:19:03","date_gmt":"2026-02-04T15:19:03","guid":{"rendered":"https:\/\/www.karoip.com\/unkategorisiert-zh-hans\/2026\/02\/spc-%e6%9d%a1%e4%be%8b%e4%b8%ad%e9%a6%96%e6%ac%a1%e4%b8%8a%e5%b8%82%e8%ae%b8%e5%8f%af%e7%9a%84%e6%9c%80%e6%96%b0%e5%8f%b8%e6%b3%95%e8%af%a0%e9%87%8a\/"},"modified":"2026-02-04T16:19:03","modified_gmt":"2026-02-04T15:19:03","slug":"spc-%e6%9d%a1%e4%be%8b%e4%b8%ad%e9%a6%96%e6%ac%a1%e4%b8%8a%e5%b8%82%e8%ae%b8%e5%8f%af%e7%9a%84%e6%9c%80%e6%96%b0%e5%8f%b8%e6%b3%95%e8%af%a0%e9%87%8a","status":"publish","type":"post","link":"https:\/\/www.karoip.com\/zh-hans\/blog-zh-hans\/patent-zh-hans\/2026\/02\/spc-%e6%9d%a1%e4%be%8b%e4%b8%ad%e9%a6%96%e6%ac%a1%e4%b8%8a%e5%b8%82%e8%ae%b8%e5%8f%af%e7%9a%84%e6%9c%80%e6%96%b0%e5%8f%b8%e6%b3%95%e8%af%a0%e9%87%8a\/","title":{"rendered":"SPC \u6761\u4f8b\u4e2d\u201c\u9996\u6b21\u4e0a\u5e02\u8bb8\u53ef\u201d\u7684\u6700\u65b0\u53f8\u6cd5\u8be0\u91ca"},"content":{"rendered":"

\u8fd1\u5e74\u6765\uff0c\u56f4\u7ed5\u300a\u6b27\u76df\u8865\u5145\u4fdd\u62a4\u8bc1\u4e66\u6761\u4f8b\u300b\uff08Regulation (EC) No 469\/2009\uff0c\u4ee5\u4e0b\u7b80\u79f0 SPC \u6761\u4f8b\uff09\u7b2c 3(d) \u6761\u4e2d\u201c\u9996\u6b21\u4e0a\u5e02\u8bb8\u53ef\uff08first marketing authorisation<\/em>\uff09\u201d\u7684\u89e3\u91ca\uff0c\u6b27\u6d32\u53f8\u6cd5\u5b9e\u8df5\u51fa\u73b0\u4e86\u663e\u8457\u5206\u6b67\uff0c\u5e76\u5f15\u53d1\u4e86\u6301\u7eed\u7684\u6cd5\u5f8b\u4e89\u8bae\u3002 <\/p>\n

\u6839\u636e SPC \u6761\u4f8b\u7b2c 3(d) \u6761\uff0c\u6388\u4e88 SPC \u7684\u524d\u63d0\u4e4b\u4e00\u662f\uff1a\u76f8\u5173\u201c\u4ea7\u54c1\u201d\uff08\u5373\u6d3b\u6027\u6210\u5206\u6216\u5176\u7ec4\u5408\uff09\u6b64\u524d\u672a\u66fe\u4f5c\u4e3a\u836f\u54c1\u5728\u6b27\u76df\u83b7\u5f97\u4e0a\u5e02\u8bb8\u53ef\u3002\u4e00\u65e6\u5b58\u5728\u4efb\u4f55\u9488\u5bf9\u540c\u4e00\u4ea7\u54c1\u7684\u65e9\u671f\u4e0a\u5e02\u8bb8\u53ef\uff0c\u540e\u7eed\u8bb8\u53ef\u539f\u5219\u4e0a\u4e0d\u518d\u6784\u6210\u201c\u9996\u6b21\u4e0a\u5e02\u8bb8\u53ef\u201d\u3002\u8fd1\u671f\u7684\u4e00\u7cfb\u5217\u6848\u4ef6\uff0c\u6b63\u662f\u56f4\u7ed5\u8fd9\u4e00\u6761\u6b3e\u7684\u89e3\u91ca\u5c55\u5f00\u3002 <\/p>\n

\u4e00\u3001Boehringer \u6848\u7684\u4e8b\u5b9e\u80cc\u666f<\/strong><\/p>\n

\u52c3\u6797\u683c\u6bb7\u683c\u7ff0\uff08Boehringer Ingelheim\uff09\u5728\u5176\u8fd1\u671f\u7684 SPC \u7533\u8bf7\u6d3b\u52a8\u4e2d\uff0c\u56e0\u4e24\u9879\u5e73\u884c\u88c1\u51b3\u800c\u5f15\u8d77\u4e86\u4e1a\u754c\u7684\u5e7f\u6cdb\u5173\u6ce8\u3002<\/p>\n

\u8be5\u6848\u7684\u57fa\u672c\u4e8b\u5b9e\u53ef\u6982\u62ec\u5982\u4e0b\uff1a<\/p>\n

Boehringer Ingelheim Vetmedica GmbH \u57fa\u4e8e\u5176\u6b27\u6d32\u4e13\u5229 EP 2 934 479\uff08\u9898\u4e3a\u201c\u7528\u4e8e\u6cbb\u7597\u9a6c\u5339\u547c\u5438\u9053\u75be\u75c5\u7684\u73af\u7d22\u5948\u5fb7\u201d\uff09\uff0c\u5e76\u4f9d\u636e\u6b27\u76df\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u4e8e 2020 \u5e74\u6388\u4e88\u7684\u517d\u533b\u836f\u54c1\u4e0a\u5e02\u8bb8\u53ef\uff08MA\uff09\uff0c\u5c31\u5176\u4ea7\u54c1 Aservo\u00ae EquiHaler\u00ae \u7533\u8bf7 SPC\u3002\u8be5\u4e0a\u5e02\u8bb8\u53ef\u4f9d\u636e\u7684\u662f\u6307\u4ee4 2001\/82\/EC\uff08\u517d\u533b\u836f\u54c1\u6307\u4ee4\uff09\u3002 <\/p>\n

\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u8fd9\u662f\u6b27\u76df\u8303\u56f4\u5185\u9996\u4e2a\u4ee5\u73af\u7d22\u5948\u5fb7\uff08ciclesonide\uff09\u4e3a\u6d3b\u6027\u6210\u5206\u7684\u517d\u533b\u4e0a\u5e02\u8bb8\u53ef\u3002\u5728\u4e0a\u5e02\u8bb8\u53ef\u7684\u5ba1\u8bc4\u8fc7\u7a0b\u4e2d\uff0cEMA \u5c06\u73af\u7d22\u5948\u5fb7\u8ba4\u5b9a\u4e3a\u6761\u4f8b (EC) No 726\/2004 \u7b2c 3(2)(a) \u6761\u610f\u4e49\u4e0a\u7684\u201c\u65b0\u6d3b\u6027\u7269\u8d28\u201d\uff0c\u5e76\u636e\u6b64\u8981\u6c42\u7533\u8bf7\u4eba\u63d0\u4ea4\u5b8c\u6574\u7684\u4e34\u5e8a\u6570\u636e\u3002 <\/p>\n

\u4e8c\u3001\u8377\u5170\u6d77\u7259\u6cd5\u9662\u7684\u5224\u51b3\uff1a\u4e25\u683c\u7684\u201c\u4ea7\u54c1\u4e2d\u5fc3\u4e3b\u4e49\u201d<\/strong><\/p>\n

\u5982\u9884\u671f\u6240\u793a\uff0c\u8be5 SPC \u7533\u8bf7\u5728\u4e0d\u540c\u6210\u5458\u56fd\u906d\u9047\u4e86\u4e0d\u540c\u7684\u547d\u8fd0\u3002\u5176\u4e2d\uff0c\u8377\u5170\u6d77\u7259\u5730\u65b9\u6cd5\u9662\u7684\u5224\u51b3\u5c24\u4e3a\u5f15\u4eba\u6ce8\u76ee\u3002 <\/p>\n

\u6d77\u7259\u6cd5\u9662\u62d2\u7edd\u6388\u4e88\u57fa\u4e8e\u4e0a\u8ff0\u517d\u533b MA \u7684 SPC\uff0c\u7406\u7531\u662f\uff1a<\/p>\n

\u5728\u8be5\u517d\u533b MA \u4e4b\u524d\uff0c\u5df2\u5b58\u5728\u4ee5\u76f8\u540c\u6d3b\u6027\u6210\u5206\u73af\u7d22\u5948\u5fb7\u4e3a\u57fa\u7840\u7684\u4eba\u7528\u836f\u54c1\u4e0a\u5e02\u8bb8\u53ef\u3002<\/p>\n

\u6cd5\u9662\u7684\u6838\u5fc3\u89c2\u70b9\u53ef\u5f52\u7eb3\u5982\u4e0b\uff1a<\/p>\n

    \n
  1. SPC \u6761\u4f8b\u7b2c 1(b) \u6761\u4e2d\u201c\u4ea7\u54c1\u201d\u7684\u5b9a\u4e49\u4ec5\u6307\u6d3b\u6027\u6210\u5206\u672c\u8eab\uff0c\u800c\u4e0d\u6d89\u53ca\u7528\u9014\u3001\u9002\u5e94\u75c7\u6216\u76d1\u7ba1\u7c7b\u522b\uff08\u4eba\u7528\u6216\u517d\u7528\uff09\u3002<\/li>\n
  2. \u4e00\u65e6\u67d0\u4e00\u6d3b\u6027\u6210\u5206\u6b64\u524d\u5df2\u83b7\u5f97\u4e0a\u5e02\u8bb8\u53ef\uff0c\u65e0\u8bba\u8be5\u8bb8\u53ef\u5c5e\u4e8e\u4eba\u7528\u836f\u54c1\u8fd8\u662f\u517d\u7528\u836f\u54c1\uff0c\u5747\u4e0d\u518d\u6ee1\u8db3\u7b2c 3(d) \u6761\u6240\u8981\u6c42\u7684\u201c\u9996\u6b21\u4e0a\u5e02\u8bb8\u53ef\u201d\u3002<\/li>\n
  3. \u662f\u5426\u6784\u6210\u201c\u9996\u6b21\u4e0a\u5e02\u8bb8\u53ef\u201d\u7684\u5224\u65ad\uff0c\u5c5e\u4e8e\u4e13\u5229\u6cd5\u5c42\u9762\u7684\u89c4\u8303\u6027\u95ee\u9898\uff0c\u5e94\u7531\u4e13\u5229\u4e3b\u7ba1\u673a\u5173\u548c\u6cd5\u9662\u51b3\u5b9a\uff0c\u800c\u975e\u836f\u54c1\u76d1\u7ba1\u673a\u6784\u7684\u804c\u6743\u8303\u56f4\u3002<\/li>\n<\/ol>\n

    \u8be5\u5224\u51b3\u4f53\u73b0\u4e86\u4e00\u79cd\u9ad8\u5ea6\u5f62\u5f0f\u5316\u3001\u4ee5\u201c\u4ea7\u54c1\u201d\u4e3a\u552f\u4e00\u5224\u65ad\u6807\u51c6\u7684\u89e3\u91ca\u8def\u5f84\u3002<\/p>\n

    \u4e09\u3001\u5fb7\u56fd\u6848\u4ef6\u7684\u79fb\u4ea4\uff1a\u95ee\u9898\u518d\u5ea6\u63d0\u4ea4\u6b27\u76df\u6cd5\u9662<\/strong><\/p>\n

    Boehringer \u540c\u65f6\u5728\u5fb7\u56fd\u63d0\u4ea4\u4e86\u76f8\u5e94\u7684 SPC \u7533\u8bf7\u30022023 \u5e74\uff0c\u8be5\u7533\u8bf7\u6700\u521d\u88ab\u5fb7\u56fd\u4e13\u5229\u5546\u6807\u5c40\uff08DPMA\uff09\u4ee5\u8fdd\u53cd SPC \u6761\u4f8b\u7b2c 3(d) \u6761\u4e3a\u7531\u62d2\u7edd\uff0c\u7406\u7531\u540c\u6837\u662f\uff1a <\/p>\n

    \u53e6\u4e00\u4f01\u4e1a\u65e9\u5728 2005 \u5e74\u5df2\u5c31\u542b\u6709\u73af\u7d22\u5948\u5fb7\u7684\u4eba\u7528\u836f\u54c1\uff08\u7528\u4e8e\u6cbb\u7597\u54ee\u5598\uff09\u83b7\u5f97\u4e0a\u5e02\u8bb8\u53ef\u3002<\/p>\n

    \u7533\u8bf7\u4eba\u968f\u5373\u63d0\u8d77\u4e0a\u8bc9\u3002\u5fb7\u56fd\u8054\u90a6\u4e13\u5229\u6cd5\u9662\uff08Bundespatentgericht\uff09\u7b2c 14 \u5408\u8bae\u5ead\u4e8e 2025 \u5e74 12 \u6708 12 \u65e5 \u4f5c\u51fa\u51b3\u5b9a\uff0c\u6682\u505c\u56fd\u5185\u7a0b\u5e8f\uff0c\u5e76\u5411\u6b27\u76df\u6cd5\u9662\u63d0\u4ea4\u4e86\u5982\u4e0b\u5148\u51b3\u95ee\u9898\uff1a <\/p>\n

    SPC \u6761\u4f8b\u7b2c 3(d) \u6761\u662f\u5426\u5e94\u88ab\u89e3\u91ca\u4e3a\uff1a
    \n\u6839\u636e\u6307\u4ee4 2001\/82\/EC \u6388\u4e88\u7684\u517d\u533b\u836f\u54c1\u4e0a\u5e02\u8bb8\u53ef\uff0c\u662f\u5426\u6784\u6210\u8be5\u4ea7\u54c1\u4f5c\u4e3a\u836f\u54c1\u6295\u653e\u5e02\u573a\u7684\u9996\u6b21\u4e0a\u5e02\u8bb8\u53ef\uff0c\u5373\u4f7f\u8be5\u4ea7\u54c1\u7684\u76f8\u540c\u6d3b\u6027\u6210\u5206\u6b64\u524d\u5df2\u4f9d\u636e\u6307\u4ee4 2001\/83\/EC \u83b7\u5f97\u4eba\u7528\u836f\u54c1\u4e0a\u5e02\u8bb8\u53ef\uff1f<\/p>\n

    \u56db\u3001Neurim \u4e0e Santen \u5224\u4f8b\u7684\u5f71\u5b50<\/strong><\/p>\n

    \u719f\u6089 SPC \u5224\u4f8b\u6cd5\u7684\u8bfb\u8005\u4e0d\u96be\u8054\u60f3\u5230\u6b27\u76df\u6cd5\u9662\u5728 Neurim \u6848\uff08C-130\/11\uff0c2012 \u5e74\uff09\u4e2d\u7684\u7ecf\u5178\u5224\u51b3\u3002<\/p>\n

    Neurim \u6848\u4e0e\u672c\u6848\u5728\u4e8b\u5b9e\u987a\u5e8f\u4e0a\u6070\u597d\u76f8\u53cd\uff1a<\/p>\n

    Neurim \u6d89\u53ca\u7684\u662f\u5148\u6709\u517d\u533b MA\uff0c\u540e\u6709\u4eba\u7528 MA\uff08\u892a\u9ed1\u6fc0\u7d20\u7528\u4e8e\u6cbb\u7597\u4eba\u7c7b\u7761\u7720\u969c\u788d\uff09\uff1b\u800c Boehringer \u6848\u5219\u662f\u5148\u6709\u4eba\u7528 MA\uff0c\u540e\u6709\u517d\u533b MA\u3002\u7136\u800c\uff0c\u4e24\u8005\u5728\u5b9e\u8d28\u4e0a\u9ad8\u5ea6\u76f8\u4f3c\u2014\u2014\u5373\uff1a <\/p>\n

    \u4e00\u4e2a\u5df2\u77e5\u6d3b\u6027\u6210\u5206\u5728\u4e0d\u540c\u76d1\u7ba1\u8def\u5f84\u4e0b\u88ab EMA \u8ba4\u5b9a\u4e3a\u201c\u65b0\u6d3b\u6027\u7269\u8d28\u201d\uff0c\u5e76\u9700\u63d0\u4ea4\u5b8c\u6574\u4e34\u5e8a\u6570\u636e\u3002<\/p>\n

    \u5728 Neurim \u6848\u4e2d\uff0c\u6b27\u76df\u6cd5\u9662\u5f3a\u8c03\uff1a\u5224\u65ad\u7b2c 3(d) \u6761\u610f\u4e49\u4e0a\u7684\u201c\u9996\u6b21\u4e0a\u5e02\u8bb8\u53ef\u201d\uff0c\u5e94\u8003\u5bdf\u65e9\u671f MA \u662f\u5426\u8986\u76d6\u4e86\u4e0e\u57fa\u7840\u4e13\u5229\u76f8\u540c\u7684\u6cbb\u7597\u7528\u9014\u3002\u7531\u6b64\uff0c\u6cd5\u9662\u5141\u8bb8\u57fa\u4e8e\u201c\u7b2c\u4e8c\u533b\u7597\u7528\u9014\u201d\u7684\u4eba\u7528 MA \u6388\u4e88 SPC\u3002<\/p>\n

    \u7136\u800c\uff0c\u8fd9\u4e00\u201c\u4fdd\u62a4\u8303\u56f4\u5bfc\u5411\u201d\u7684\u89e3\u91ca\u8def\u5f84\uff0c\u5728 Santen \u6848\uff08C-673\/18\uff0c2020 \u5e74\uff09\u4e2d\u88ab\u6b27\u76df\u6cd5\u9662\u660e\u786e\u653e\u5f03\u3002Santen \u6848\u56de\u5f52\u5230\u4e25\u683c\u7684\u201c\u4ea7\u54c1\u4e2d\u5fc3\u4e3b\u4e49\u201d\uff0c\u5426\u5b9a\u4e86\u57fa\u4e8e\u65b0\u6cbb\u7597\u7528\u9014\u6388\u4e88 SPC \u7684\u53ef\u80fd\u6027\u3002 <\/p>\n

    \u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0cSanten \u5224\u51b3\u5e76\u672a\u5904\u7406\u5982\u4e0b\u7279\u6b8a\u60c5\u5f62\uff1a<\/p>\n

    \u5373\uff0c\u5f53\u67d0\u4e00\u5df2\u77e5\u6d3b\u6027\u6210\u5206\u88ab\u76d1\u7ba1\u673a\u6784\u8ba4\u5b9a\u4e3a\u201c\u65b0\u6d3b\u6027\u7269\u8d28\u201d\uff0c\u5e76\u56e0\u6b64\u89e6\u53d1\u5b8c\u6574\u3001\u72ec\u7acb\u7684\u5ba1\u6279\u7a0b\u5e8f\u65f6\uff0c\u5e94\u5982\u4f55\u9002\u7528\u7b2c 3(d) \u6761\u3002<\/p>\n

    \u4e94\u3001\u5fb7\u56fd\u6cd5\u9662\u7684\u7acb\u573a\u4e0e\u5236\u5ea6\u8003\u91cf<\/strong><\/p>\n

    \u5728\u6b64\u6b21\u79fb\u4ea4\u51b3\u5b9a\u4e2d\uff0c\u5fb7\u56fd\u8054\u90a6\u4e13\u5229\u6cd5\u9662\u660e\u663e\u503e\u5411\u4e8e\u5c06\u6d89\u6848\u517d\u533b MA \u89c6\u4e3a\u7b2c 3(d) \u6761\u610f\u4e49\u4e0a\u7684\u201c\u9996\u6b21\u4e0a\u5e02\u8bb8\u53ef\u201d\uff0c\u5373\u4fbf\u6b64\u524d\u5df2\u5b58\u5728\u4eba\u7528 MA\u3002<\/p>\n

    \u5176\u7406\u7531\u4e3b\u8981\u5728\u4e8e SPC \u5236\u5ea6\u7684\u7acb\u6cd5\u76ee\u7684\uff1a<\/p>\n

      \n
    • \u6839\u636e\u6307\u4ee4 2001\/83\/EC\uff08\u4eba\u7528\u836f\u54c1\uff09\u83b7\u5f97\u7684\u4e34\u5e8a\u6570\u636e\uff0c\u901a\u5e38\u65e0\u6cd5\u76f4\u63a5\u7528\u4e8e\u52a0\u901f\u6307\u4ee4 2001\/82\/EC\uff08\u517d\u533b\u836f\u54c1\uff09\u4e0b\u7684\u5ba1\u6279\u7a0b\u5e8f\uff0c\u53cd\u4e4b\u4ea6\u7136\uff1b<\/li>\n
    • \u82e5\u4ec5\u56e0\u5b58\u5728\u65e9\u671f\u7684\u4eba\u7528\u6216\u517d\u7528 MA \u800c\u5426\u5b9a SPC\uff0c\u5c06\u53ef\u80fd\u5728\u5b9e\u8df5\u4e2d\u9020\u6210\u771f\u5b9e\u7684\u4fdd\u62a4\u7f3a\u53e3\uff1b<\/li>\n
    • \u8fd9\u79cd\u89e3\u91ca\u8fd8\u53ef\u80fd\u524a\u5f31\u5236\u836f\u4f01\u4e1a\u5728\u4ea4\u53c9\u9886\u57df\uff08\u4eba\u7528\/\u517d\u7528\uff09\u5f00\u5c55\u7814\u53d1\u6295\u5165\u7684\u79ef\u6781\u6027\u3002<\/li>\n<\/ul>\n

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