Classification of Vaccines as Biological Medicines, Use of the Terms “Biologics/Biogenic Agents,” and Regulatory Implications for Consent
SPENCER JONES made this Official Information request to Ministry of Health
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From: SPENCER JONES
To: Medsafe (Ministry of Health)
Via: FYI.org.nz
Official Information Act Request
I request the following official information from Medsafe under the OIA.
1. Definitions and Classification Framework
Please provide:
1.1 The current regulatory definitions used by Medsafe for the following terms:
“biological product”
“biologic medicine”
“biogenic agent”
“biological agent”
“biotechnological product”
“immunobiologic”
“vaccine”
1.2 Any internal Medsafe documents, manuals, classification tables, regulatory glossaries, or policy documents that define or distinguish the above terms.
1.3 Any documents discussing whether vaccines fall under the categories “biologics,” “biogenic agents,” or “biological medicines” for regulatory purposes.
2. Historical and Policy Changes Since 2015
Please provide:
2.1 All documents that record or explain any changes in Medsafe’s classification of vaccines or biologics since 1 January 2015.
2.2 Any internal or external memos, briefing notes, policy proposals, or consultation papers relating to revisions of vaccine classification or terminology.
2.3 Any documents referencing alignment with foreign regulators (e.g., FDA, EMA, TGA, MHRA, WHO) regarding:
classification of vaccines as biologics
wording used in regulatory guidance
terminology used in patient-facing materials
3. Consent and Labeling Interactions
Please provide:
3.1 Any Medsafe analysis, policy, review, or legal interpretation addressing whether classification of a medicine as a “biologic” or “biological product” has any effect on:
informed-consent requirements
patient rights
consumer safety labelling
hospital or general practice consent forms
3.2 Any correspondence (internal or external) discussing whether the terms “biologic,” “biological product,” or “biogenic agent” appear in:
hospital consent forms
pre-operative consent forms
vaccination consent documents
product safety sheets
Medsafe advisories
3.3 Any documented policy position by Medsafe on whether the classification of vaccines as “biologics” requires, changes, or affects the nature of informed consent for vaccination.
4. International Regulatory Context
Please provide:
4.1 Any Medsafe documents (internal or external) referencing the long-standing classification of vaccines as biologics under:
the 1902 U.S. Biologics Control Act
Section 351 of the U.S. Public Health Service Act
EMA/WHO standards
ICH/ICHQ5 guidelines
International Council for Harmonisation biologics definitions
4.2 Any internal Medsafe briefings explaining why vaccines are classified as biologics and how the classification has historically evolved.
5. Communications and Public Messaging
Please provide:
5.1 Any public-relations, communications, or media-advice documents Medsafe has produced since 2019 regarding the terminology:
“biologic”
“biological medicine”
“vaccine as a biologic”
“biotechnology-derived vaccine”
5.2 Any internal correspondence concerning public confusion or questions about the use of the term “biologic/biological product” vs “vaccine”.
5.3 Any instructions provided to DHBs/Te Whatu Ora, GPs, pharmacists, or health staff regarding language to use (or avoid) around “biologics” in patient-facing materials.
Kind regards,
Spencer Jones
From: SPENCER JONES
To: Medsafe (Ministry of Health)
Via: FYI.org.nz
Official Information Act Request
I request the following official information from Medsafe under the OIA.
1. Definitions and Classification Framework
Please provide:
1.1 The current regulatory definitions used by Medsafe for the following terms:
“biological product”
“biologic medicine”
“biogenic agent”
“biological agent”
“biotechnological product”
“immunobiologic”
“vaccine”
1.2 Any internal Medsafe documents, manuals, classification tables, regulatory glossaries, or policy documents that define or distinguish the above terms.
1.3 Any documents discussing whether vaccines fall under the categories “biologics,” “biogenic agents,” or “biological medicines” for regulatory purposes.
2. Historical and Policy Changes Since 2015
Please provide:
2.1 All documents that record or explain any changes in Medsafe’s classification of vaccines or biologics since 1 January 2015.
2.2 Any internal or external memos, briefing notes, policy proposals, or consultation papers relating to revisions of vaccine classification or terminology.
2.3 Any documents referencing alignment with foreign regulators (e.g., FDA, EMA, TGA, MHRA, WHO) regarding:
classification of vaccines as biologics
wording used in regulatory guidance
terminology used in patient-facing materials
3. Consent and Labeling Interactions
Please provide:
3.1 Any Medsafe analysis, policy, review, or legal interpretation addressing whether classification of a medicine as a “biologic” or “biological product” has any effect on:
informed-consent requirements
patient rights
consumer safety labelling
hospital or general practice consent forms
3.2 Any correspondence (internal or external) discussing whether the terms “biologic,” “biological product,” or “biogenic agent” appear in:
hospital consent forms
pre-operative consent forms
vaccination consent documents
product safety sheets
Medsafe advisories
3.3 Any documented policy position by Medsafe on whether the classification of vaccines as “biologics” requires, changes, or affects the nature of informed consent for vaccination.
4. International Regulatory Context
Please provide:
4.1 Any Medsafe documents (internal or external) referencing the long-standing classification of vaccines as biologics under:
the 1902 U.S. Biologics Control Act
Section 351 of the U.S. Public Health Service Act
EMA/WHO standards
ICH/ICHQ5 guidelines
International Council for Harmonisation biologics definitions
4.2 Any internal Medsafe briefings explaining why vaccines are classified as biologics and how the classification has historically evolved.
5. Communications and Public Messaging
Please provide:
5.1 Any public-relations, communications, or media-advice documents Medsafe has produced since 2019 regarding the terminology:
“biologic”
“biological medicine”
“vaccine as a biologic”
“biotechnology-derived vaccine”
5.2 Any internal correspondence concerning public confusion or questions about the use of the term “biologic/biological product” vs “vaccine”.
5.3 Any instructions provided to DHBs/Te Whatu Ora, GPs, pharmacists, or health staff regarding language to use (or avoid) around “biologics” in patient-facing materials.
6. OIA / Public Requests History
Please provide:
6.1 A list (or copies) of all OIA responses since 2018 that mention:
“biologic”
“biological product”
“biogenic agent”
“vaccine classification”
“informed consent & biologics”
“hospital consent form + biologics”
6.2 Any internal discussions about rising public interest in vaccine classification or biologics classification.
7. Product Classification Examples
Please provide:
7.1 All classification documents for vaccines currently approved in New Zealand that explicitly refer to their regulatory status as:
biologics
biological medicines
biological products
biotechnology-derived products
7.2 Any explanatory notes for sponsors regarding biologic classification under the Medicines Act.
Format Request
I request all information in electronic format.
If any information is withheld, please specify the exact grounds under the OIA and provide partial release where applicable.
Kind regards,
Spencer Jones
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- Download a zip file of all correspondence (note: this contains the same information already available above).
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SPENCER JONES left an annotation ()
Annotation for readers following this request:
This OIA examines a simple but important transparency question:
How does Medsafe define “biologics,” and where do vaccines fit within that terminology?
Vaccines have been classified as biologics internationally since 1902 (Biologics Control Act) — a fact often misunderstood in public discussions. This classification is not new, secret, or conspiratorial.
However:
NZ hospitals sometimes use broad consent language like “blood products, biologics, or medications deemed necessary,”
Medsafe’s internal definitions are not publicly published,
No NZ OIA has ever asked how these terms are defined,
No NZ document clearly states whether hospital terminology includes or excludes vaccines,
And no research has mapped how this classification interacts with informed-consent law.
This OIA does not allege wrongdoing.
It seeks clarity, definitions, and policy transparency, so patients and practitioners understand:
what “biologics” means in NZ,
what it includes,
whether vaccines are included in that term (regulatory vs. clinical use),
and whether classification affects informed-consent obligations.
This request is intended to support truth, accuracy, and public integrity by:
clarifying terminology,
preventing misinformation or misinterpretation,
and ensuring NZ regulatory definitions are publicly accessible.
Updates will be posted when Medsafe responds.
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