7. The Second Schedule to the principal Regulations is amended —(a) | by deleting the word “traceability” in paragraph 1(1)(a) and substituting the words “product tracking”; | (b) | by inserting, immediately before the words “the name of the substance” in paragraph 1(2)(e), the words “in the case of a therapeutic product,”; | (c) | by inserting, immediately after sub‑paragraph (e) of paragraph 1(2), the following sub‑paragraph:“(ea) | in the case of an applicable CTGT product, the name of the CTGT product and a description, expressed qualitatively and quantitatively, of any active substance in the CTGT product, as well as, in the case of blinded trials, the name of the comparator or placebo;”; |
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| (d) | by deleting the full‑stop at the end of sub‑paragraph (j) of paragraph 1(2) and substituting a semi‑colon, and by inserting immediately thereafter the following sub‑paragraphs:“(k) | in the case of an autologous applicable CTGT product, the unique patient identifier and the words “for autologous use only” or similar wordings; | (l) | in the case of an applicable CTGT product, the list of excipients, including preservative systems (if applicable), for the CTGT product; | (m) | in the case of an applicable CTGT product, any warning that is necessary for the CTGT product; | (n) | in the case of an applicable CTGT product, any precaution relating to the disposal of any unused CTGT product or any waste derived from the CTGT product (where appropriate) and any available collection system for the unused CTGT product or waste.”; |
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| (e) | by deleting the word “and” in paragraph 1(3)(e) and substituting the word “or”; | (f) | by inserting, immediately before the words “where the appropriate” in paragraph 1(3)(f), the words “in the case of a therapeutic product,”; | (g) | by inserting, immediately after sub‑paragraph (f) of paragraph 1(3), the following sub‑paragraph:“(fa) | in the case of an applicable CTGT product, the name of the CTGT product and a description, expressed qualitatively and quantitatively, of any active substance in the CTGT product;”; |
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| (h) | by deleting the full‑stop at the end of sub‑paragraph (k) of paragraph 1(3) and substituting a semi‑colon, and by inserting immediately thereafter the following sub‑paragraphs:“(l) | the conditions under which the product must be stored; | (m) | in the case of an autologous applicable CTGT product, the unique patient identifier and the words “for autologous use only” or similar wordings; | (n) | in the case of an applicable CTGT product, the list of excipients, including preservative systems (if applicable), for the CTGT product; | (o) | in the case of an applicable CTGT product, any warning that is necessary for the CTGT product; | (p) | in the case of an applicable CTGT product, any precaution relating to the disposal of any unused CTGT product or any waste derived from the CTGT product (where appropriate) and any available collection system for the unused CTGT product or waste.”; |
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| (i) | by deleting the word “and” in paragraph 1(4)(c) and substituting the word “or”; | (j) | by inserting, immediately before the words “where the appropriate” in paragraph 1(4)(d), the words “in the case of a therapeutic product,”; | (k) | by inserting, immediately after sub‑paragraph (d) of paragraph 1(4), the following sub‑paragraph:“(da) | in the case of an applicable CTGT product, the name of the CTGT product and a description, expressed qualitatively and quantitatively, of any active substance in the CTGT product;”; |
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| (l) | by deleting the full‑stop at the end of sub‑paragraph (i) of paragraph 1(4) and substituting a semi‑colon, and by inserting immediately thereafter the following sub‑paragraphs:“(j) | the conditions under which the product must be stored; | (k) | in the case of an autologous applicable CTGT product, the unique patient identifier and the words “for autologous use only” or similar wordings; | (l) | in the case of an applicable CTGT product, the list of excipients, including preservative systems (if applicable), for the CTGT product; | (m) | in the case of an applicable CTGT product, any warning that is necessary for the CTGT product; | (n) | in the case of an applicable CTGT product, any precaution relating to the disposal of any unused CTGT product or any waste derived from the CTGT product (where appropriate) and any available collection system for the unused CTGT product or waste.”; |
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| (m) | by deleting the words “sub‑paragraph (2)(b), (c), (d) and (f) to (i)” in paragraph 1(8) and substituting the words “sub‑paragraphs (2)(b), (c), (d) and (f) to (i), (3)(a), (b), (d), (g), (j), (k) and (4)(b), (e), (h) and (i)”; | (n) | by inserting, immediately after sub‑paragraph (8) of paragraph 1, the following sub‑paragraph:“(9) In this paragraph, “autologous”, in relation to an applicable CTGT product, means a CTGT product that contains cells or tissue that are obtained only from the individual to whom the CTGT product is to be administered.”; and |
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| (o) | by deleting paragraph 2. |
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